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

Model Number	24681
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.A 7.0 x40, 75cm charger balloon catheter was advanced for dilatation; however, during procedure the shaft of the balloon broke and had to be snared out of the body.The procedure was completed and there were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 7.0 x40, 75cm charger balloon catheter was advanced for dilatation; however, during procedure the shaft of the balloon broke and had to be snared out of the body.The procedure was completed and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: a charger device 18 atm was received for analysis.A visual examination of the shaft identified an inner balloon shaft break 4mm proximal from the proximal markerband.A visual examination identified complete circumferential tear 5mm distal from the proximal balloon sleeve.A visual examination observed no damage to the tip of the device.A visual examination found no issues or damage to the markerbands of the device.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16030192
• Report Number: 2124215-2022-51872
• Device Sequence Number: 7475128
• Product Code: FGE
• UDI-Device Identifier: 08714729804536
• UDI-Public: 08714729804536
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2025
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0029642279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown