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

Model Number M0061752520

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was open to be used during an intracorporeal stone fragmentation procedure performed on (b)(6) 2020.According to the complainant, during unpacking, it was noticed that a part of the catheter was detached.Another percuflex plus ureteral stent was opened was opened, and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code 1069 captures the reportable event of stent shaft broken.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail at the proximal section was detached.The suture string was returned un-cut and loaded in the detached bladder pigtail section.No other issues with the device were noted.The reported event was not confirmed.The investigation revealed that the bladder pigtail at the proximal section was detached, which could have been interpreted by the customer as stent shaft break.Based on the product analysis, the suture string was returned un-cut and loaded in the detached bladder pigtail section, evidence that the stent was manipulated out of the package.The problem found, bladder pigtail detached, was is an issue that could have been generated by the user or due to the interacting 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.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was open to be used during an intracorporeal stone fragmentation procedure performed on (b)(6) 2020.According to the complainant, during unpacking, it was noticed that a part of the catheter was detached.Another percuflex plus ureteral stent was opened was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10606119
• MDR Text Key: 209158418
• Report Number: 3005099803-2020-04247
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0023965733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1