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	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the femoral artery.A 6.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, during the inflation at 5 atmospheres, the balloon ruptured.The device was removed and no balloon fragments left on the patient's body.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient's status was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the femoral artery.A 6.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, during the inflation at 5 atmospheres, the balloon ruptured.The device was removed and no balloon fragments left on the patient's body.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient's status was fine.It was further reported that the target lesion was 50% stenosed and was located in the non-tortuous and moderately calcified vessel.The balloon was inflated once before it ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the femoral artery.A 6.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.However, during the inflation at 5 atmospheres, the balloon ruptured.The device was removed and no balloon fragments left on the patient's body.The procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient's status was fine.It was further reported that the target lesion was 50% stenosed and was located in the non-tortuous and moderately calcified vessel.The balloon was inflated once before it ruptured.
Additional Manufacturer Narrative
D4.Lot number: corrected from 25976762 to 26077796.D4.Expiration date: correction from 09/07/2023 to 09/25/2023.D4.Unique identifier (udi) #: corrected from (b)(4).H4: device manufacture date corrected from 09/07/2020 to 09/25/2020.Device evaluation by mfr: the mustang 6 x60, 75cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 24mm proximal from the distal markerband.The inflation device was verified at 24 atmospheres before and after use with a calibrated pressure gauge.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11324402
• Report Number: 2134265-2021-01691
• Device Sequence Number: 4010752
• Product Code: FGE
• UDI-Device Identifier: 08714729793939
• UDI-Public: 08714729793939
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2021

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: 09/25/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026077796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 04/15/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/19/2021; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR