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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon pinhole was encountered.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilation.However, during inflation, it was noticed that the balloon did not hold pressure and a small hole in the proximal portion was observed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter city: (b)(6).Device evaluated by mfr.: mustang 12.0 x 40, 135cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 14 mm proximally of the proximal marker band.An examination of the balloon material and the proximal marker band identified no issues.A visual and microscopic examination of the marker bands identified no issues.A visual and tactile examination found no issues with the device shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon pinhole was encountered.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilation.However, during inflation, it was noticed that the balloon did not hold pressure and a small hole in the proximal portion was observed.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's 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: 9438331
• Report Number: 2134265-2019-15182
• Device Sequence Number: 2934573
• Product Code: FGE
• UDI-Device Identifier: 08714729793953
• UDI-Public: 08714729793953
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 07/09/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022352329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR