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

Model Number 24674

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

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft break occurred.The patient presented with nephritis.A 6.0 x 80, 40cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the device was broken.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.

Manufacturer Narrative

E1- facility name: (b)(6) hospital.E1 - initial reporter phone: +(b)(6).

Event Description

It was reported that shaft break occurred.The patient presented with nephritis.A 6.0 x 80, 40cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the device was broken.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the balloon ruptured, and the shaft did not break as what was previously reported.The target lesion was 70% stenosed, moderately tortuous and severely calcified.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18029566
• MDR Text Key: 326851781
• Report Number: 2124215-2023-60018
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729795148
• UDI-Public: 08714729795148
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/06/2023

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 Expiration Date: 12/01/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026441276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG