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

Model Number 1094-04

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 333049045
• Report Number: 2124215-2024-00482
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729178613
• UDI-Public: 08714729178613
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention