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

Model Number	M0061752520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).(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 percuflex plus ureteral stent was opened to be used during a procedure in the ureter, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the package, it was noticed that the stent was fractured.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.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6).Block h6: device code 1069 captures the reportable event of stent shaft break.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail was detached and the suture hole was torn.The suture string was not returned with the device.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 suture string was not returned with the device and the suture hole is torn, evidence that of the stent was manipulated out of the package.The problem found, bladder pigtail detached and suture hole torn, were issues that could have been generated by the user or due to the interaction of the device with the suture string during an improper device manipulation.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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was opened to be used during a procedure in the ureter, performed on (b)(6) 2020.According to the complainant, when the physician unpacked the package, it was noticed that the stent was fractured.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.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10867659
• Report Number: 3005099803-2020-05581
• Device Sequence Number: 2862923
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/16/2020

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: 07/02/2022
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0024052948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 60