MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION URETERAL CATHETER; CATHETER, URETHRAL

Model Number	M0064002111
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a flexima 5f cone tip ureteral catheter was used in the kidney during a ureteroscopy procedure performed on (b)(6) 2022.During the procedure, when the device was implanted, it was noticed that the cone tip portion of the catheter was sharp and pierced through the ureteral orifice.The device was then removed immediately, and the procedure was completed with an open-ended catheter.It is unknown how exactly the catheter pierced the ureteral orifice.There was no reported treatment performed for the patient injury.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (patient outcome), d7a (sud reprocessed and reused), h8 (usage of device) block h6: conclusion code d14 is being used to capture that the event is no longer reportable.Block h10: investigation result the visual examination of the returned complaint device found that the shaft has no kinks or torns and their luer cap was not returned.A tactile analysis was performed and passing the finger along the catheter but nothing sharp was felt.Additionally, the device was inspected against the cosmetic inspection and a little burr was noted at the tip of the device which is according to the cosmetic procedure the size is allowable.Microscopic examination was performed, and it was found that the tip of the catheter did not identify major issue.No problems with the device were noted.The reported event of was not confirmed.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event (visual, physical and performance testing).Therefore, the most probable root cause for this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction: block b1, b2 (product problem), h1 (type of reportable event), h6 (patient code, impact code).
Event or Problem Description
It was reported to boston scientific corporation that a flexima 5f cone tip ureteral catheter was used in the kidney during a ureteroscopy procedure performed on (b)(6) 2 022.During the procedure, when the device was implanted, it was noticed that the cone tip portion of the catheter was sharp and pierced through the ureteral orifice.The device was then removed immediately, and the procedure was completed with an open-ended catheter.It is unknown how exactly the catheter pierced the ureteral orifice.There was no reported treatment performed for the patient injury.No further information has been obtained despite good faith efforts.***additional information received on december 7, 2022*** it was reported that there were no patient injury and no patient complications reported as a result of this event.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15941269
• Report Number: 3005099803-2022-07164
• Device Sequence Number: 17743502
• Product Code: GBM
• UDI-Device Identifier: 08714729342168
• UDI-Public: 08714729342168
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2025
• Device Model Number: M0064002111
• Device Catalogue Number: 400-211
• Device Lot Number: 0029295734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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 Sex: Male