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 09/24/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 19-nov 2021.In (b)(6) 2021, the patient presented with pain in left lower limb and percutaneous intraarterial balloon dilation was performed.The patient was treated from the right leg over the hill to the left leg.A radiograph revealed a segment of stenosis in the left iliac artery.A 6.0 x 40, 135cm mustang balloon catheter was advanced for dilation.However, when the balloon was primed at 8 atmospheres, it was found to be leaking but no pinhole was noted.The balloon was pulled out and the procedure was completed with another of same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed a balloon pinhole.

Manufacturer Narrative

Device evaluated by mfr: a mustang device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.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 13mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per mustang specification the rated burst pressure for this device is 24 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12879575
• MDR Text Key: 281431833
• Report Number: 2134265-2021-14894
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793472
• UDI-Public: 08714729793472
• 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: 11/26/2021

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 Expiration Date: 03/09/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026944235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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 Age: 67 YR
• Patient Sex: Female