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

Model Number	M0061752730
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).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 percuflex plus ureteral stent was used during a cysto, stent placement procedure in the ureter, performed on (b)(6) 2021.During the procedure and inside the patient, it was noticed that the wire shredded in the stent and had to be cut out.The stent and wire were removed without incident from the patient.Another percuflex plus ureteral stent was used to successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0414 captures the reportable event of stent torn inside the patient.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that a part of the amplatz guidewire was stuck inside the stent.The bladder section of the stent including the suture hole was torn.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the amplatz guidewire was stuck in the catheter, evidence that the stent was manipulated.The problem found could be generated by the user and due to the interacting/handling of the device with the suture string.The problem could have occurred because of an excess of force applied when the stent was trying to be placed while interacting with other devices.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device was unable to be performed as lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a cysto, stent placement procedure in the ureter, performed on (b)(6) 2021.During the procedure and inside the patient, it was noticed that the wire shredded in the stent and had to be cut out.The stent and wire were removed without incident from the patient.Another percuflex plus ureteral stent was used to successfully completed the procedure.There were no patient complications reported as a result of this event.

• 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: 11809410
• Report Number: 3005099803-2021-02164
• Device Sequence Number: 14311808
• Product Code: FAD
• UDI-Device Identifier: 08714729041207
• UDI-Public: 08714729041207
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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 Model Number: M0061752730
• Device Catalogue Number: 175-273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1