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

Model Number 24672

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a balloon rupture and catheter shaft break occurred.A 7.0 x 120, 75cm mustang balloon catheter was advanced for dilation.After an unknown number of inflations, the balloon burst.The device was removed from the patient, and upon retrieval, the catheter shaft fractured distal to the balloon.The detached portion was removed by removing the entire guidewire system.The procedure was completed with another of the same device.There were no reported patient complications.

Manufacturer Narrative

E1 - initial reporter phone: (b)(6).Corrected field: b5 - describe event or problem: additional event details were provided on (b)(6) 2023 that were not included in the initial report submission on (b)(6) 2023.

Event Description

It was reported that a balloon rupture and catheter shaft break occurred.A 7.0 x 120, 75cm mustang balloon catheter was advanced for dilation.After an unknown number of inflations, the balloon burst.The device was removed from the patient, and upon retrieval, the catheter shaft fractured distal to the balloon.The detached portion was removed by removing the entire guidewire system.The procedure was completed with another of the same device.There were no reported patient complications.It was further reported that prior to insertion of the mustang balloon, the lesion was pre-dilated using an unknown 4-5mm balloon.The mustang balloon was inflated to approximately 10-14atm prior to bursting.Additionally, approximately 35cm of the catheter shaft fractured within the patient.

Event Description

It was reported that a balloon rupture and catheter shaft break occurred.A 7.0 x 120, 75cm mustang balloon catheter was advanced for dilation.After an unknown number of inflations, the balloon burst.The device was removed from the patient, and upon retrieval, the catheter shaft fractured distal to the balloon.The detached portion was removed by removing the entire guidewire system.The procedure was completed with another of the same device.There were no reported patient complications.It was further reported that prior to insertion of the mustang balloon, the lesion was pre-dilated using an unknown 4-5mm balloon.The mustang balloon was inflated to approximately 10-14atm prior to bursting.Additionally, approximately 35cm of the catheter shaft fractured within the patient.

Manufacturer Narrative

Device analysis: the device was received was received in two sections due to a complete separation of the shaft.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 2mm distal of the proximal balloon bond.From the complete circumferential tear, the distal section of balloon material was also torn longitudinally along its entire length.A visual and tactile examination of the shaft found a complete separation of the shaft located approximately 2mm distal of the proximal balloon bond.Severe stretching damage and kinking was also noted to the distal section of shaft.The distal marker band was displaced due to the shaft damage and the proximal marker band was not returned for analysis.No issues were noted with the tip of the device.No other issues were identified during the product analysis.Images were provided by the customer depicting the damaged device.E1 - initial reporter phone: (b)(6).Corrected field: b5 - describe event or problem: additional event details were provided on 30aug2023 that were not included in the initial report submission on 21sep2023.

• 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: 17793595
• MDR Text Key: 324015898
• Report Number: 2124215-2023-47493
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794424
• UDI-Public: 08714729794424
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103751
• 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,Followup,Followup
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0031090136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 08/30/2023; 11/28/2023
• Supplement Dates FDA Received: 09/29/2023; 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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