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	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arteriovenous fistula.Two 10.0 x 60, 75cm and one 10.0 x 40, 75cm mustang balloon catheters were selected to treat the lesion.However, the balloons ruptured upon inflation despite being high-pressure balloons.The procedure was completed a non-boston scientific balloon catheter.There were no complications reported and the patient was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arteriovenous fistula.Two 10.0 x 60, 75cm and one 10.0 x 40, 75cm mustang balloon catheters were selected to treat the lesion.However, the balloons ruptured upon inflation despite being high-pressure balloons.The procedure was completed a non-boston scientific balloon catheter.There were no complications reported and the patient was stable.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: a mustang 10.0 x 60, 75cm was received for analysis.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.A visual examination identified a balloon longitudinal tear beginning approximately 10mm proximal of the proximal markerband and extending approximately 70mm distally 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 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.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.

• 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: 12957557
• Report Number: 2134265-2021-15377
• Device Sequence Number: 1854554
• Product Code: FGE
• UDI-Device Identifier: 08714729794004
• UDI-Public: 08714729794004
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 03/01/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026895760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown