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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula in the central vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluation by mfr: the mustang device 10x8x7cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.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 10mm proximal of the proximal 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 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.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula in the central vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries were reported.It was further reported that the target lesion was 75% stenosed with less than 45 degrees bend, severely calcified and severely tortuous.The balloon was inflated once at 10 atmospheres for 1 second before it ruptured and was completely removed from the patient.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula in the central vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications nor injuries were reported.It was further reported that the target lesion was 75% stenosed with less than 45 degrees bend, severely calcified and severely tortuous.The balloon was inflated once at 10 atmospheres for 1 second before it ruptured and was completely removed from the patient.

• 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: 11556183
• Report Number: 2134265-2021-03770
• Device Sequence Number: 17194540
• Product Code: FGE
• UDI-Device Identifier: 08714729794332
• UDI-Public: 08714729794332
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141521
• 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,Followup
• Report Date (Section B): 05/12/2021

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: 02/12/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025207226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/26/2021; 04/29/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/02/2021; 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR