MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date not provided.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.An 8.0 x100, 135cm charger balloon catheter was advanced for dilation.However, during inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another 8x100 charger balloon catheter.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.An 8.0 x100, 135cm charger balloon catheter was advanced for dilation.However, during inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another 8x100 charger balloon catheter.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured at 10 atmospheres and the device was completely removed through sheath using standard extracting process.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since event date not provided.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12232736
• Report Number: 2134265-2021-09646
• Device Sequence Number: 3761432
• Product Code: LIT
• UDI-Device Identifier: 08714729804574
• UDI-Public: 08714729804574
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 11/10/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0026332418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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