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

Model Number	24674
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in a shunt in an anastomotic vessel.An encore 26 inflation device was used together with a 6.0 x 80, 40cm mustang balloon catheter in a percutaneous transluminal angioplasty.However, during the procedure, the balloon did not inflate, and the applied pressure did not increase.It was then suspected that the balloon had ruptured.The device was replaced with a new balloon; however, the pressure still did not increase.The procedure was completed by operating the inflation device by force.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.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 inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure for 30 seconds using deionizes water and digital timer, without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per mustang specification the rated burst pressure for this device is 24 atmospheres.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in a shunt in an anastomotic vessel.An encore 26 inflation device was used together with a 6.0 x 80, 40cm mustang balloon catheter in a percutaneous transluminal angioplasty.However, during the procedure, the balloon did not inflate, and the applied pressure did not increase.It was then suspected that the balloon had ruptured.The device was replaced with a new balloon; however, the pressure still did not increase.The procedure was completed by operating the inflation device by force.No patient complications nor injuries were reported.

• Brand Name: MUSTANG
• Common Device Name: 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: 18474448
• Report Number: 2124215-2023-74948
• Device Sequence Number: 6944100
• Product Code: FGE
• UDI-Device Identifier: 08714729795148
• UDI-Public: 08714729795148
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030656730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown