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

Model Number	1094-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• 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: 18147667
• Report Number: 2124215-2023-60618
• Device Sequence Number: 15329162
• Product Code: FAD
• UDI-Device Identifier: 08714729048633
• UDI-Public: 08714729048633
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 07/20/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• 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