MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL

Model Number	M0061802220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hematuria (2558)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used in a stent placement procedure for stone management for stones in the left ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the contour ureteral stent was placed for stone management for stone; laser lithotripsy (with or without extraction) under fluoroscopy and cystoscopy in the left ureter.No issues were reported with the device during placement.The procedure was performed without any complications.Discharge medication included non-steroidal anti-inflammatory drugs (nsaids).There is no information if a new stent was implanted.During post procedure, the patient experienced severe left lumbar pain during urination and mild hematuria without clot.The patient was given tramadol as medication for pain and hematuria.The relationship of the adverse event to the device and the procedure was reportedly to be probably related.On (b)(6) 2022, a planned stent removal procedure was performed, the stent was successfully removed without any difficulty.Pain control of local anesthesia was required.There were no new device implanted.No issues were noted with the devices during removal.On (b)(6) 2022 the event was considered resolved.A complication of severe left lumbar pain and mild hematuria was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e2330 captures the reportable event of pain.Patient code e1302 captures the reportable event of hematuria.Impact code f2303 captures the reportable event medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block b5 has been updated based on the additional information received on september 16, 2022.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used in a stent placement procedure for stone management for stones in the left ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the contour ureteral stent was placed for stone management for stone; laser lithotripsy (with or without extraction) under fluoroscopy and cystoscopy in the left ureter.No issues were reported with the device during placement.The procedure was performed without any complications.Discharge medication included non-steroidal anti-inflammatory drugs (nsaids).There is no information if a new stent was implanted.During post procedure, the patient experienced severe left lumbar pain during urination and mild hematuria without clot.The patient was given tramadol as medication for pain and hematuria.The relationship of the adverse event to the device and the procedure was reportedly to be probably related.On (b)(6) 2022, a planned stent removal procedure was performed, the stent was successfully removed without any difficulty.Pain control of local anesthesia was required.There were no new device implanted.No issues were noted with the devices during removal.On july 11, 2022 the event was considered resolved.A complication of severe left lumbar pain and mild hematuria was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.Additional information was received on september 16, 2022 stating that in the physician's assessment the data reasonably suggest the clinical events left lumbar pain while urinating, treated with tramadol, and slight hematuria (without clots), treated with medication, are anticipated in nature and severity as per the ifu and hazard analysis.Both events were reported to be probably related to the procedure and device and not related to stent removal.It is noted the patient was being treated for a uti and is pregnant, which could be contributors to back pain.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code e2330 captures the reportable event of pain.Patient code e1302 captures the reportable event of hematuria.Impact code f2303 captures the reportable event medication required.Block h11: additional information block b5 has been updated based on the additional information received on (b)(6) 2022.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used in a stent placement procedure for stone management for stones in the left ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the contour ureteral stent was placed for stone management for stone; laser lithotripsy (with or without extraction) under fluoroscopy and cystoscopy in the left ureter.No issues were reported with the device during placement.The procedure was performed without any complications.Discharge medication included non-steroidal anti-inflammatory drugs (nsaids).There is no information if a new stent was implanted.During post procedure, the patient experienced severe left lumbar pain during urination and mild hematuria without clot.The patient was given tramadol as medication for pain and hematuria.The relationship of the adverse event to the device and the procedure was reportedly to be probably related.On (b)(6) 2022, a planned stent removal procedure was performed, the stent was successfully removed without any difficulty.Pain control of local anesthesia was required.There were no new device implanted.No issues were noted with the devices during removal.Additional information was received on (b)(6) 2022 stating that the contour ureteral stent was not removed.Additional information was received on (b)(6) 2022 stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as (b)(6) 2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.On (b)(6) 2022 the event was considered resolved.A complication of severe left lumbar pain and mild hematuria was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.Additional information was received on (b)(6) 2022 stating that in the physician's assessment the data reasonably suggest the clinical events left lumbar pain while urinating, treated with tramadol, and slight hematuria (without clots), treated with medication, are anticipated in nature and severity as per the ifu and hazard analysis.Both events were reported to be probably related to the procedure and device and not related to stent removal.It is noted the patient was being treated for a uti and is pregnant, which could be contributors to back pain.Additional information was received on (b)(6) 2022 stating that the contour ureteral stent was not removed.Additional information was received on (b)(6) 2022 stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as (b)(6) 2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used in a stent placement procedure for stone management for stones in the left ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the contour ureteral stent was placed for stone management for stone; laser lithotripsy (with or without extraction) under fluoroscopy and cystoscopy in the left ureter.No issues were reported with the device during placement.The procedure was performed without any complications.Discharge medication included non-steroidal anti-inflammatory drugs (nsaids).There is no information if a new stent was implanted.During post procedure, the patient experienced severe left lumbar pain during urination and mild hematuria without clot.The patient was given tramadol as medication for pain and hematuria.The relationship of the adverse event to the device and the procedure was reportedly to be probably related.On (b)(6) 2022, a planned stent removal procedure was performed, the stent was successfully removed without any difficulty.Pain control of local anesthesia was required.There were no new device implanted.No issues were noted with the devices during removal.Additional information was received on november 04, 2022 stating that the contour ureteral stent was not removed.Additional information was received on november 16, 2022 stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as july 11, 2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.On july 11, 2022 the event was considered resolved.A complication of severe left lumbar pain and mild hematuria was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to have fully recovered.Additional information was received on september 16, 2022 stating that in the physician's assessment the data reasonably suggest the clinical events left lumbar pain while urinating, treated with tramadol, and slight hematuria (without clots), treated with medication, are anticipated in nature and severity as per the ifu and hazard analysis.Both events were reported to be probably related to the procedure and device and not related to stent removal.It is noted the patient was being treated for a uti and is pregnant, which could be contributors to back pain.Additional information was received on november 04, 2022 stating that the contour ureteral stent was not removed.Additional information was received on november 16, 2022 stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as july 11, 2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.Additional information was received on january 04, 2023 stating that the adverse event of slight hematuria without clots onset date was on july 05, 2022.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient code (b)(6) captures the reportable event of pain.Patient code (b)(6) captures the reportable event of hematuria.Impact code (b)(6) captures the reportable event medication required.Block h11: additional information: block b5 has been updated based on the additional information received on january 04, 2023.Block b6 relevant tests/laboratory data; block e1 initial reporter first name and initial reporter last name has been corrected.

• Brand Name: CONTOUR
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15263327
• Report Number: 3005099803-2022-04579
• Device Sequence Number: 14844473
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: 08714729058502
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 09/16/2022; 11/04/2022; 12/27/2022
• Initial Report FDA Received Date: 08/20/2022
• Supplement Report FDA Received Date: 10/11/2022; 11/30/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female