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

Model Number 1094-04

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2023

Event Type  Injury  

Event Description

It was reported that the device got dislodged inside the patient.A balloon dilatation catheter kit was selected for use.During the procedure, it was noted that the ureteral stent radio-opaque band, at distal end became dislodged inside the patient.They tried to snare ro band but was unsuccessful.There were no patient complications reported post procedure.

Event Description

It was reported that the device got dislodged inside the patient.A balloon dilatation catheter kit was selected for use.During the procedure, it was noted that the ureteral stent radio-opaque band, at distal end became dislodged inside the patient.They tried to snare ro band but was unsuccessful.There were no patient complications reported post procedure.

Manufacturer Narrative

Device eval by manufacturer: the stabilizer cannula was returned for analysis.Visual inspection was performed on the device, and it was observed that the radio-opaque (ro) marker was missing.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Factors such as excessive handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure could have possibly affected the device performance and integrity.

• 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: 18147667
• MDR Text Key: 328261674
• Report Number: 2124215-2023-60618
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729048633
• UDI-Public: 08714729048633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 0032065316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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