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

Model Number	24674
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in an arteriovenous fistula in a tortous unspecified vessel.A 8.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during procedure, the balloon broke off in the patient and had to be retrieved.Broken pieces were removed with a snare and forceps.The device came out in three pieces.No further information available.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in an arteriovenous fistula in a tortous unspecified vessel.A 8.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during procedure, the balloon broke off in the patient and had to be retrieved.Broken pieces were removed with a snare and forceps.The device came out in three pieces.No further information available.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang device was received for analysis.The shaft of the device was received in three sections due to three shaft breaks and the balloon material was received in three sections due to two complete circumferential balloon tears.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Two complete balloon circumferential tears were identified.The first tear was located approximately 10mm distal of the proximal balloon sleeve and the second was located approximately 40mm proximal of the distal tip.This type of damage most probably occurred when the device was being withdrawn through the sheath.The rated burst pressure for this device as per mustang specification is 20 atmospheres.A visual and microscopic examination observed damage to the tip of the device.This type of damage is consistent with resistance being encountered and excessive force being applied to the device when crossing the lesion.A visual and tactile examination found the shaft of the device to have completely detached at three locations.The first break was located approximately 70mm distal of the hub/manifold.The second and third breaks were located at both the distal and proximal balloon bonds.Severe stretching damage was also noted to the distal section of the detached shaft.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination found one of the markerbands to have completely detached from the device.The detached markerband was not returned for analysis.The second markerband was undamaged and in place on the shaft.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: 10988430
• Report Number: 2134265-2020-17275
• Device Sequence Number: 19719864
• Product Code: FGE
• UDI-Device Identifier: 08714729793885
• UDI-Public: 08714729793885
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026182240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention