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	01/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The chronic totally occluded target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.Two mustang balloon catheters (6.0 x 40,135cm and 6.0 x 60,135cm) were advanced for pre-dilatation.Both balloons ruptured during first inflation at 10 atmospheres nominal pressure for 30 seconds and contrast leakage was noted.The device was removed.Non-bsc devices also ruptured.A drug-eluting stent was deployed and the procedure completed.No patient serious injury or adverse events were reported and the patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.A microscopic examination identified a longitudinal tear on the balloon material beginning approximately 11mm proximal of the distal markerband and extending approximately 17mm proximally across the balloon material.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 issues with the tip of the device which could potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The chronic totally occluded target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.Two mustang balloon catheters (6.0 x 40,135cm and 6.0 x 60,135cm) were advanced for pre-dilatation.Both balloons ruptured during first inflation at 10 atmospheres nominal pressure for 30 seconds and contrast leakage was noted.The device was removed.Non-bsc devices also ruptured.A drug-eluting stent was deployed and the procedure completed.No patient serious injury or adverse events were reported and the patient status was fine.

• 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: 8281523
• Report Number: 2134265-2019-00301
• Device Sequence Number: 11282824
• Product Code: FGE
• UDI-Device Identifier: 08714729793939
• UDI-Public: 08714729793939
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/19/2019

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: Other
• Device Expiration Date: 09/11/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022639835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR