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	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that balloon rupture occurred.The 80% stenosed target lesion was located in the subclavian artery.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation, the pressure could no longer be increased after reaching 4 atmospheres (atm), despite that the rated burst pressure was 20 atm.When the balloon was withdrawn, upon pressure decreasing, it was noted, that the contrast in the pump was mixed with blood.Indicating, that the balloon was leaking.After removal from the patient's body, liquid was injected into the balloon with a syringe.And it was noted, that there was a pinhole on the balloon body.The procedure was completed with a new 10x40 mustang balloon, followed by a 10x37 bsc ld stent.There were no patient complications nor injuries reported.And the patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter facility: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the subclavian artery.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during initial inflation, the pressure could no longer be increased after reaching 4 atmospheres (atm), despite that the rated burst pressure was 20 atm.When the balloon was withdrawn, upon pressure decreasing, it was noted that the contrast in the pump was mixed with blood, indicating that the balloon was leaking.After removal from the patient's body, liquid was injected into the balloon with a syringe, and it was noted that there was a pinhole on the balloon body.The procedure was completed with a new 10x40 mustang balloon followed by a 10x37 bsc ld stent.There were no patient complications nor injuries reported, and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 33mm in length and extended from a position 23mm proximal of the distal markerband to 8mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.E1: (b)(6).

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17218374
• Report Number: 2124215-2023-33705
• Device Sequence Number: 20391396
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: 08714729793823
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 06/17/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029613817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 67 KG