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

Model Number	M0064002111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter drainage device was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the catheter broke off at the end and created a barbed sharp tip.Reportedly, the broken catheter was removed from the scope, and the procedure was completed with another flexima ureteral catheter drainage.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Additional information: block b5 block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 1069 captures the reportable issue of catheter broken.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter drainage device was used in the ureter during a ureteroscopy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, it was noted that the catheter broke off at the end and created a barbed sharp tip.Reportedly, the broken catheter was removed from the scope, and the procedure was completed with another flexima ureteral catheter drainage.There were no patient complications reported as a result of this event.**additional information received on (b)(6) 2020** reportedly, the tip broke off during unpacking.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11010942
• Report Number: 3005099803-2020-06168
• Device Sequence Number: 17042766
• Product Code: GBM
• UDI-Device Identifier: 08714729342168
• UDI-Public: 08714729342168
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: M0064002111
• Device Catalogue Number: 400-211
• Device Lot Number: 0024863602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1