MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752620
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2017
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus ureteral stent was implanted during a transurethral cystoscopy procedure performed on (b)(6) 2017.According to the complainant, the physician placed the percuflex¿ plus ureteral stent and then used a cystoscope to check the positioning of the stent.Reportedly, the retrieval line was thought to have cut through the stent, detaching the distal pigtail and leaving it free floating in the bladder.The stent was removed from the ureter.Separately, the detached pigtail piece was successfully removed from the bladder using removal forceps.The procedure was successfully completed with another percuflex¿ plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
A visual analysis of the returned device revealed that the bladder pigtail was found detached.No other anomalies or damages were noted.Based on the condition of the returned device, the complaint was confirmed.Based on the information available, the complaint is due to known physiological effects of the procedure noted within the directions for use (dfu).Therefore, the most probable root cause of this complaint is anticipated procedural complication.The device history record review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus ureteral stent was implanted during a transurethral cystoscopy procedure performed on (b)(6) 2017.According to the complainant, the physician placed the percuflex¿ plus ureteral stent and then used a cystoscope to check the positioning of the stent.Reportedly, the retrieval line was thought to have cut through the stent, detaching the distal pigtail and leaving it free floating in the bladder.The stent was removed from the ureter.Separately, the detached pigtail piece was successfully removed from the bladder using removal forceps.The procedure was successfully completed with another percuflex¿ plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: PERCUFLEX¿ PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6430054
• Report Number: 3005099803-2017-00699
• Device Sequence Number: 1102419
• Product Code: FGE
• UDI-Device Identifier: 08714729056829
• UDI-Public: (01)08714729056829(17)20191124(10)19997131
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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: Health Professional
• Device Expiration Date: 11/24/2019
• Device Model Number: M0061752620
• Device Catalogue Number: 175-262
• Device Lot Number: 19997131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/25/2017
• 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