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

Model Number M006175263010

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: grupo emequr michoacan - col.Jardines del bosque, jalisco initial reporter state: michoacan device code 1069 captures the reportable event of stent shaft break.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a percuflex ureteral stent was open to be used during a flexible ureteroscopy with laser procedure in the ureter for bilateral nephrolithiasis, performed on (b)(6) 2020.According to the complainant, when the physician removed the stent from the packaging, it was noticed that the stent shaft was broken in the middle.Another percuflex ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Initial reporter state: (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.Block h10: the returned percuflex plus ureteral was analyzed, and a visual evaluation noted that the middle section of the stent was detached and the suture hole was torn.Photos were attached in the complaint record and shows the device without the suture string and out of original package.The suture string was not returned with the device.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the middle section of the ureteral stent was detached/separated.Additionally, the device was returned out of original pouch and without the suture string, evidence that the stent was manipulated during use.The problems that were found could have been generated by the user or due to the interacting/handling/manipulation of the device with the suture string during preparation and improper manipulation during procedure.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during preparation and the device had no influence on the 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 ureteral stent was open to be used during a flexible ureteroscopy with laser procedure in the ureter for bilateral nephrolithiasis, performed on (b)(6) 2020.According to the complainant, when the physician removed the stent from the packaging, it was noticed that the stent shaft was broken in the middle.Another percuflex ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• 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: 10844345
• MDR Text Key: 226077258
• Report Number: 3005099803-2020-05396
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729302032
• UDI-Public: 08714729302032
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: M006175263010
• Device Catalogue Number: 175-263-01
• Device Lot Number: 0025423142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR