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

Model Number 24674

Device Problems Difficult to Remove (1528); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 10mm proximal of the distal markerband.The proximal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending for approximately 32mm proximally.No other issues were noted with the balloon material.As per specification, the rated burst pressure for this device is 24 atmospheres with a maximum of 10 inflations and compatible with a minimum 5fr sheath.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at approximately 4mm proximal of the distal markerband.This type of damage is consistent with excessive force being applied to the device.Both markerbands were undamaged and present on the shaft of the device.

Event Description

It was reported that the balloon ruptured, and additional incision occurred.The 90% stenosed target lesion was in a shunt located in the moderately tortuous and moderately calcified blood vessel.A 6.0 x 40, 75cm mustang balloon was advanced for dilation.During the procedure, a puncture was performed from the cephalic vein of the forearm, and a total of four stenosis up to the cephalic arch, and inflation was performed from the distal part of the puncture.However, during the fourteenth inflation at 24 atmospheres for 30 seconds, the balloon ruptured.The balloon ruptured horizontally and could not be pulled into the sheath.It was difficult to remove the sheath, so the skin was incised about 3 mm with a spitz scalpel and stitched with about 5 stitches.No complications were observed for the patient other than the additional incision.

• Brand Name: MUSTANG
• Type of Device: 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: 18993232
• MDR Text Key: 338816926
• Report Number: 2124215-2024-15320
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793335
• UDI-Public: 08714729793335
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032495542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE - RADIFOCUS 0.035; INTRODUCER SHEATH - ULTRA HIGH FLOW 5F
• Patient Outcome(s): Required Intervention