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

Model Number	24672
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon burst circumferentially and detached.A 7.0 x 150, 75cm mustang balloon was selected for use in a percutaneous transluminal angioplasty (pta) of the 90% stenosed, mildly tortuous and severely calcified superficial femoral artery (sfa).During the first inflation, the balloon burst circumferentially approximately 5cm from the tip.During removal, the distal portion broke off and was able to be removed from the patient still on the guidewire with out any complications.The procedure was completed with another device and no patient complications were reported.
Additional Manufacturer Narrative
Device/media analysis: the device was received in two sections due to a shaft break and a complete balloon circumferential tear.Visual examination identified the tear was located approximately 105mm distal of the proximal balloon sleeve.This type of damage most probably occurred when the device was being withdrawn through the sheath prior to a balloon rupture.The rated burst pressure for this device as per specifications is 18 atmospheres.For investigation purposes, the investigator dissected the distal section of balloon material to identify the location of a shaft break and one of the markerbands.No issues were noted with the markerbands.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device with a section of the balloon to have completely detached at approximately 55mm proximal of the distal tip.The balloon inner shaft was noted to be severely stretched and accordioned.This type of damage is consistent with excessive tensile force being applied to the device.
Event or Problem Description
It was reported the balloon burst circumferentially and detached.A 7.0 x 150, 75cm mustang balloon was selected for use in a percutaneous transluminal angioplasty (pta) of the 90% stenosed, mildly tortuous, and severely calcified superficial femoral artery (sfa).During the first inflation, the balloon burst circumferentially approximately 5cm from the tip.During removal, the distal portion broke off and was able to be removed from the patient, still on the guidewire, without any complications.The procedure was completed with another device and no patient complications were reported.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12953475
• Report Number: 2134265-2021-15398
• Device Sequence Number: 17216432
• Product Code: LIT
• UDI-Device Identifier: 08714729794578
• UDI-Public: 08714729794578
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 09/24/2023
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0026069326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown