MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER OVER-THE-WIRE PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939206070670
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon burst during procedure.Burst atmospheric pressure was 18, balloon burst at 14.This was the third inflation with this balloon and burst atmospheric pressure was never reached.

• Brand Name: CHARGER OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752 1234
• MDR Report Key: 16226550
• Report Number: MW5114440
• Device Sequence Number: 6871287
• Product Code: LIT
• UDI-Device Identifier: 08714729804543
• UDI-Public: 08714729804543
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: H74939206070670
• Device Catalogue Number: H74939206070670
• Device Lot Number: 29880970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Hispanic