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

Model Number 24672

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 35% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and moderately calcified brachiocephalic artery.A 6.0 x 120, 75cm mustang balloon catheter was advanced for dilatation.The balloon was attempted to be inflated twice at 4-6 atmospheres, however, the balloon could not be inflated to nominal pressure.The device was removed from the patient and upon checking, there was a small hole at the tip of the balloon.The physician used an inflation device to inflate the balloon at 4 atmospheres and noticed that there is a small leak.The procedure was completed with another 6.0mm x 80mm 75cm mustang balloon catheter.No patient complications were reported.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 35% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and moderately calcified brachiocephalic artery.A 6.0 x 120, 75cm mustang balloon catheter was advanced for dilatation.The balloon was attempted to be inflated twice at 4-6 atmospheres, however, the balloon could not be inflated to nominal pressure.The device was removed from the patient and upon checking, there was a small hole at the tip of the balloon.The physician used an inflation device to inflate the balloon at 4 atmospheres and noticed that there is a small leak.The procedure was completed with another 6.0mm x 80mm 75cm mustang balloon catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: mustang 6.0 x 120, 75cm.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 at the distal edge of the distal markerband.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 in the correct position on the shaft of the device.This concludes the product analysis.

Event Description

It was reported that balloon rupture occurred.The 35% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and moderately calcified brachiocephalic artery.A 6.0 x 120, 75cm mustang balloon catheter was advanced for dilatation.The balloon was attempted to be inflated twice at 4-6 atmospheres, however, the balloon could not be inflated to nominal pressure.The device was removed from the patient and upon checking, there was a small hole at the tip of the balloon.The physician used an inflation device to inflate the balloon at 4 atmospheres and noticed that there is a small leak.The procedure was completed with another 6.0mm x 80mm 75cm mustang balloon catheter.No patient complications were reported.

• Brand Name: MUSTANG
• Type of Device: 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: 15566511
• MDR Text Key: 306610649
• Report Number: 2124215-2022-37427
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794127
• UDI-Public: 08714729794127
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

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
• Device Operator: Health Professional
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0029796454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/12/2022; 11/28/2022
• Supplement Dates FDA Received: 10/27/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• 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
• Patient Race: Asian