MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER 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	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 was used during a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the catheter broke inside the patient but were successfully retrieved, though it is unknown how the pieces were retrieved.The patient's condition after the procedure was reported to be okay.Attempts to obtain additional information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.No patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the complaint device revealed that the catheter was broken in two pieces and both catheter sections were bent in several locations.The noted failures likely occurred due to anatomical or procedural factors which limited the performance of the balloon.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and no anomalies were found.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the bladder and ureter during a cystoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the catheter broke inside the patient but were successfully retrieved, though it is unknown how the pieces were retrieved.No patient complications reported as a result of this event.The patient's condition after the procedure was reported to be okay.
Additional Manufacturer Narrative
Additional information received: block device available for evaluation, device evaluated by mfr have been updated.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 was used in the bladder and ureter during a cystoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the catheter broke inside the patient but were successfully retrieved, though it is unknown how the pieces were retrieved.No patient complications reported as a result of this event.The patient's condition after the procedure was reported to be okay.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6827311
• Report Number: 3005099803-2017-02684
• Device Sequence Number: 16451105
• Product Code: GBM
• UDI-Device Identifier: 08714729342168
• UDI-Public: (01)08714729342168(17)20180430(10)17935392
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• 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,Followup
• Report Date (Section B): 08/30/2017

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: M0064002111
• Device Catalogue Number: 400-211
• Device Lot Number: 17935392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 09/27/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 09/14/2017; 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention