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

Model Number 24674

Device Problem Deflation Problem (1149)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

It was reported that balloon deflation issue occurred.The target lesion was located in a vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for dilation.However, during deflation, the balloon failed to deflate even with multiple attempts.The balloon was removed fully inflated and the procedure was completed with another balloon.There were no patient complications nor injuries reported.

Manufacturer Narrative

Device evaluation by mfr: a mustang balloon catheter was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon deflated fully in 09 seconds.The deflation time was verified using digital timer.The balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.The times were measured at 16, 18, 15 seconds.The inflation device was verified at 14 atmospheres before and after use with a calibrated pressure.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.No issues were noted with the returned device which may have potentially contributed to the complaint incident.

Event Description

It was reported that balloon deflation issue occurred.The target lesion was located in a vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for dilation.However, during deflation, the balloon failed to deflate even with multiple attempts.The balloon was removed fully inflated and the procedure was completed with another balloon.There were no patient complications nor injuries reported.It was further reported that target lesion was moderately stenosed, non-tortuous, and non-calcified.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12291320
• MDR Text Key: 265565956
• Report Number: 2134265-2021-09755
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729795230
• UDI-Public: 08714729795230
• Combination Product (y/n): N
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026797838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1