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

Model Number 24674

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that removal difficulty occurred.The 75% stenosed target lesion was located in a shunt percutaneous transluminal angioplasty.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilation.However, during the removal, the sheath was caught.The device was removed but the shaft was stretched, and the procedure was completed with a similar device.There were no patient complications reported, and the patient was in good condition after the procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded and displayed evidence that it been inflated.No issues were identified with the balloon.A visual examination found no damage to the tip of the device.A visual examination found no damage or issues with the markerbands of the device.A visual and tactile examination found the shaft of the device to have stretching damage beginning approximately 60mm proximal of the proximal balloon bond and extending approximately 20mm proximally.This type of damage is consistent with excessive tensile force being applied to the device.

Event Description

It was reported that removal difficulty occurred.The 75% stenosed target lesion was located in a shunt percutaneous transluminal angioplasty.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilation.However, during the removal, the sheath was caught.The device was removed but the shaft was stretched, and the procedure was completed with a similar device.There were no patient complications reported, and the patient was in good condition after the procedure.

• 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: 18357826
• MDR Text Key: 331192347
• Report Number: 2124215-2023-72176
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793625
• UDI-Public: 08714729793625
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0031869136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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 - 35WIRE; GUIDEWIRE - 35WIRE; INTRODUCER SHEATH - 5F SHEATH; INTRODUCER SHEATH - 5F SHEATH