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

Model Number 24674

Device Problem Leak/Splash (1354)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).Device evaluated by mfr.: mustang 8.0 x 40, 135cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm proximal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at the proximal balloon sleeve.This type of damage is consistent with excessive force being applied to the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.

Event Description

Reportable based on device analysis completed on 20-dec-2022.It was reported that balloon leak occurred.The patient presented with femoral artery stenosis.The 85% stenosed target lesion with no significant bend was located in the moderately tortuous and non-calcified left lower extremity femoral artery.The patient was placed in a supine position and vascular access was obtained via the right femoral artery.After inserting a 6f non-boston scientific (bsc) sheath, a 0.035 x 260mm guidewire was used to cross the lesion.A 8.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during the initial inflation at 2 atmospheres (atm), it was found that there was contrast agent leaking at the tail end of the balloon.The balloon was withdrawn from the patient and the procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable post-procedure.However, returned device analysis revealed a balloon pinhole.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16059334
• MDR Text Key: 308016979
• Report Number: 2124215-2022-54287
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028634362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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
• Treatment: GUIDE CATHETER - 6F COOK SHEATH
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG