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

Model Number	24672
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon pinhole occurred.The 4-5mmx150mm, eccentric, de novo target lesion with approximately 80% stenosis and fibrous-lipidica plaque was located in the mildly calcified and non-tortuous superficial femoral artery.A 4.0 x 150mm, 135cm mustang balloon catheter was advanced for dilation.However, during inflation at 14 atmospheres for 2 minutes, the pressure was lost.A pinhole and leak were noted on the distal part of the balloon after being withdrawn.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by mfr.: a mustang balloon 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 27mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip.No kinks or damage were noted along the shaft of the device.
Event or Problem Description
It was reported that balloon pinhole occurred.The 4-5mmx150mm, eccentric, de novo target lesion with approximately 80% stenosis and fibrous-lipidica plaque was located in the mildly calcified and non-tortuous superficial femoral artery.A 4.0 x 150mm, 135cm mustang balloon catheter was advanced for dilation.However, during inflation at 14 atmospheres for 2 minutes, the pressure was lost.A pinhole and leak were noted on the distal part of the balloon after being withdrawn.No patient complications were reported and the patient status was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12025637
• Report Number: 2134265-2021-07844
• Device Sequence Number: 1374945
• Product Code: LIT
• UDI-Device Identifier: 08714729793694
• UDI-Public: 08714729793694
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0024876284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 62