MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study: u0652 double-j registry clinical study.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was to reported to boston scientific corporation that a two previously implanted percuflex plus ureteral stent was removed from the left and right ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the left and right ureter, and the patient was prescribed the discharge medications acetaminophen (tylenol) and narcotic analgesics (opioids).No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left and right flank pain.The patient was given tylenol, ibuprofen, urine sample, and flomax to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new device implanted.On (b)(6) 2022 the event was considered resolved.
Event or Problem Description
Note: this report pertains to the first of two devices that were used in the same procedure.It was to reported to boston scientific corporation that a two previously implanted percuflex plus ureteral stent was removed from the left and right ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the left and right ureter, and the patient was prescribed the discharge medications acetaminophen (tylenol) and narcotic analgesics (opioids).No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left and right flank pain.The patient was given tylenol, ibuprofen, urine sample, and flomax to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new device implanted.On april 19, 2022 the event was considered resolved.
Additional Manufacturer Narrative
Block g3: study: (b)(6) double-j registry clinical study.Block h6: medical problem code e2330 is being used to capture the reportable issue of pain.Patient impact code f2303 captures the reportable event of medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block b6: removed the statement "the patient had a medical history of bowel disease".And moved to block b7 (other relevant history).

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 14458841
• Report Number: 3005099803-2022-02774
• Device Sequence Number: 19976011
• Product Code: FAD
• UDI-Device Identifier: 08714729041191
• UDI-Public: 08714729041191
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2024
• Device Model Number: M0061752640
• Device Catalogue Number: 175-264
• Device Lot Number: 0028264601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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: 64 YR
• Patient Sex: Male