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

Model Number	24672
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an unobstructed and non-tortuous left common iliac artery.A 5.0 x 120, 135cm mustang balloon catheter was advanced for dilation.However, on initial inflation, there was leakage of dye noted from the balloon and the balloon could not increase pressure.A very small hole was noted at the edge of the balloon.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an unobstructed and non-tortuous left common iliac artery.A 5.0 x 120, 135cm mustang balloon catheter was advanced for dilation.However, on initial inflation, there was leakage of dye noted from the balloon and the balloon could not increase pressure.A very small hole was noted at the edge of the balloon.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang 5.0 x 120, 135cm was returned for analysis.A visual analysis identified a longitudinal balloon tear in the balloon starting at the proximal markerband and extending approximately 10mm distally.A visual and microscopic examination of the balloon material identified no other issues.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.

• 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: 10341083
• Report Number: 2134265-2020-09231
• Device Sequence Number: 3557375
• Product Code: FGE
• UDI-Device Identifier: 08714729793410
• UDI-Public: 08714729793410
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 01/01/2023
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0024975714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 70