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

Model Number	1094-04
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent broke off and was removed with a snare.The target lesion was in the left kidney.A percuflex temperature ablation catheter ureteral stent was selected for use.During the procedure, it was noted that the stent was placed in a normal fashion.The stabilizer was being removed when the proximal loop broke off a few centimeters from the tapered end.The two pieces of the device were in the patient at this point.The doctor decided to attempt to retrieve the pieces the following day, so a nephrostomy tube was kept in place so that they had access for the retrieval procedure and the broken device was retrieved via snare the next day.Hence, the physician felt that the tube broke from the pulling of the string.The procedure was completed with another percuflex stent.The patient has fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: only the stent was returned for analysis.It was observed that the stent was detached and buckled or accordioned at pigtail section.Also, the suture hole is ripped or torn, and the suture was missing from the catheter.
Event or Problem Description
It was reported that the stent broke off and was removed with a snare.The target lesion was in the left kidney.A percuflex temperature ablation catheter ureteral stent was selected for use.During the procedure, it was noted that the stent was placed in a normal fashion.The stabilizer was being removed when the proximal loop broke off a few centimeters from the tapered end.The two pieces of the device were in the patient at this point.The doctor decided to attempt to retrieve the pieces the following day, so a nephrostomy tube was kept in place so that they had access for the retrieval procedure and the broken device was retrieved via snare the next day.Hence, the physician felt that the tube broke from the pulling of the string.The procedure was completed with another percuflex stent.The patient has fully recovered.

• Brand Name: PERCUFLEX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18527609
• Report Number: 2124215-2024-00482
• Device Sequence Number: 20433729
• Product Code: FAD
• UDI-Device Identifier: 08714729178613
• UDI-Public: 08714729178613
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 05/21/2026
• Device Model Number: 1094-04
• Device Catalogue Number: 1094-04
• Device Lot Number: 0031667456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown