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	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the subclavian artery.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at nominal bar, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the subclavian artery.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at nominal bar, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the target lesion was 80% stenosed, moderately calcified and non-tortuous.In addition, the balloon ruptured on the first inflation at 3 atmospheres.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.Device evaluated by mfr: mustang 7.0 x 60, 75cm, 20atm 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 19mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per mustang specification the rated burst pressure for this device is 20 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely kinked at approximately 3mm proximal of the proximal markerband.This type of damage is consistent with excess force being applied to 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.This concludes the product analysis.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the subclavian artery.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at nominal bar, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the target lesion was 80% stenosed, moderately calcified and non-tortuous.In addition, the balloon ruptured on the first inflation at 3 atmospheres.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15262587
• Report Number: 2124215-2022-30430
• Device Sequence Number: 17551154
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: 08714729793861
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2022

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: 01/03/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028618612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 08/31/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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