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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 used during a flexible ureteroscopy procedure, performed on (b)(6) 2021.It was reported that when the physician unpacked the package, it was noticed that the stent was "burst".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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block d4,h4 was updated based off ai from product investigation on may 21, 2021.Block e1: initial reporter state: 11.Block h6: medical device problem code a0401 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 detached and the suture hole torn.The suture string was returned loaded in a different position of the suture hole.A functional inspection revealed that a mandrel 0.0353" was attempted to be loaded but it was not possible because of the cut in the detached tip and occlusion in the detached sections.No other problems were found in the device.The reported event was not confirmed.Analysis of the returned device revealed that the device was found with the bladder pigtail detached and suture hole torn.It is possible that the customer could have perceived the problem as stent shaft break.According to product analysis, suture string was returned loaded in a different position of the suture hole in the bladder pigtail section detached, evidence that the stent was manipulated out of the package.The problem found are issues that could have been generated by the user or due to the interacting/handling of the device with the suture string or other devices.The kind of cut found in the tip could have been caused by an excess of force during manipulation.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.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 used during a flexible ureteroscopy procedure, performed on (b)(6), 2021.It was reported that when the physician unpacked the package, it was noticed that the stent was "burst".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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 11419076
• Report Number: 3005099803-2021-00858
• Device Sequence Number: 2854777
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/16/2021

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 Expiration Date: 04/25/2022
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0023701980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR