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

Model Number	1094-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch (b)(4) that the pigtail catheter tip broke and was snared to remove.A percuflex guide catheter was selected for use in ureteral stent placement (stent from kidney to bladder).During the procedure, upon placing a boston scientific right ureteral stent system, it was noted that the pigtail tip located in the kidney broke.The physician was able to snare the broken loop and the procedure was completed after snaring the broken piece of the pigtail catheter.Imaging was reviewed indicating that the ureteral stent was functioning appropriately at the end of the case.No patient complications were reported.

• Brand Name: PERCUFLEX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12366128
• Report Number: 2134265-2021-10740
• Device Sequence Number: 4633229
• Product Code: FAD
• UDI-Device Identifier: 08714729170556
• UDI-Public: 08714729170556
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2024
• Device Model Number: 1094-04
• Device Catalogue Number: 1094-04
• Device Lot Number: 0026913303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR