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

Model Number	24674
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the left lower extremity.A 12.0 x 80, 135cm mustang balloon catheter was advanced to dilate the lesion.However, during the first inflation at 12 atmospheres, the balloon burst and detached into two parts.Half remained inside the patient and surgery was performed to take the fragments out.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination identified a that the balloon material had torn circumferentially completely at three locations.The first circumferential tear is located approximately 10mm proximal of the tip.This tear extends longitudinally for approximately 50mm to the second circumferential tear approximately at the middle of the balloon which extends longitudinally for approximately 45mm to the third circumferential tear.Approximately 5mm of balloon material remained attached to the shaft of the device.A visual and tactile examination identified that the shaft was completely broken at two locations.The first break was located approximately 1240mm distal of the strain relief.The second break was located at the tip of the device.The detached section of shaft which also has both markerbands attached was not returned for analysis.The markerbands of the device were not returned for analysis.A visual and microscopic examination identified that the tip of the returned device was severely damaged.This type of damage is consistent with excessive force being applied as the user attempts to cross a lesion with the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the left lower extremity.A 12.0 x 80, 135cm mustang balloon catheter was advanced to dilate the lesion.However, during the first inflation at 12 atmospheres, the balloon burst and detached into two parts.Half remained inside the patient and surgery was performed to take the fragments out.No patient complications were reported and the patient 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: 8112576
• Report Number: 2134265-2018-63195
• Device Sequence Number: 11192831
• Product Code: FGE
• UDI-Device Identifier: 08714729795285
• UDI-Public: 08714729795285
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/10/2019

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: 07/04/2021
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0022338344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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
• Patient Age: 49 YR
• Patient Weight: 60