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

Model Number M0061752640

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that an percuflex plus ureteral stent was opened to be used during a procedure, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the package, it was noticed that the stent was fractured in two pieces.Another percuflex plus ureteral stent was opened, and successfully completed the procedure.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 stable.

Event Description

It was reported to boston scientific corporation that an percuflex plus ureteral stent was opened to be used during a procedure, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the package, it was noticed that the stent was fractured in two pieces.Another percuflex plus ureteral stent was opened and successfully completed the procedure.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 stable.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: device code 1069 captures the reportable event of stent shaft break.Block h10: the returned percuflex plus stent was analyzed, and a visual evaluation noted that the bladder pigtail was detached.The suture string was returned properly cut and loaded in the bladder pigtail section detached.No other issues with the device were noted.The reported event was confirmed.The investigation revealed that the bladder pigtail was detached, which could have been interpreted by the customer as stent shaft break.Based on the product analysis, the problem found, bladder pigtail detached, could have been generated by the user or due to the interaction of the device with the suture string.Adverse event related to procedure is selected as the most probable root cause for the complaint since it is the most likely that the adverse event occurred during procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: PERCUFLEX PLUS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10714777
• MDR Text Key: 212725448
• Report Number: 3005099803-2020-04815
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729041191
• UDI-Public: 08714729041191
• Combination Product (y/n): N
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: M0061752640
• Device Catalogue Number: 175-264
• Device Lot Number: 0023610533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1