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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial artery.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial artery.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured during the first inflation at 20 atmospheres.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 7.0 x 80, 75cm, batch# (b)(6), 20atm was received for analysis.A visual examination identified that the balloon was not folded, and inflation media was present inside it which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure for 30 seconds using digital timer without issue.A vacuum was then applied.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.A visual examination of the marker bands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with tip of this device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial artery.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured during the first inflation at 20 atmospheres.It was further reported that the lesion was 70% stenosed and was moderately tortuous and moderately calcified.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13112903
• Report Number: 2134265-2021-16307
• Device Sequence Number: 16967956
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: 08714729794264
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

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: 06/13/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027491280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 01/21/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/17/2022; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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 Age: 71 YR
• Patient Sex: Male