MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	3855
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 05/01/2024 as no event date was reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured in the patient.The procedure was completed with a different device.No patient complications reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured in the patient.The procedure was completed with a different device.No patient complications reported.It was further reported that this event was reported via medwatch (b)(4).The balloon was removed and replaced without harm to the patient.
Additional Manufacturer Narrative
B3 date of event: date of event was approximated to 05/01/2024 as no event date was reported.
Additional Manufacturer Narrative
Block h2 correction: block h10 (related report number field).Block h6: imdrf device code a0401 captures the reportable event of basket wire break.This is for the same event as manufacturer reports 2124215-2024-47935.User facility reference # (b)(4).
Event or Problem Description
It was reported that a balloon rupture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured in the patient.The procedure was completed with a different device.No patient complications reported.It was further reported that this event was reported via medwatch (b)(4).The balloon was removed and replaced without harm to the patient.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19530351
• Report Number: 2124215-2024-36211
• Device Sequence Number: 7574889
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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: 03/20/2026
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0033671011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 08/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/27/2024
• Date Device Manufactured: 03/20/2024
• 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 Sex: Unknown