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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Perforation (2001); Obstruction/Occlusion (2422); Pericardial Effusion (3271)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

Literature citation: abdelhakim allali md1,2, 2022, combined rotational atherectomy and cutting balloon angioplasty prior to drug eluting stent implantation in severely calcified coronary lesions: the prepare calc combo study, catheter cardiovascular interv.2022;1 11.Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.

Event Description

It was reported via a journal article multiple adverse injuries occurred.Rotapro and wolverine devices were selected for treatment in percutaneous coronary intervention procedures as a part of a medical study.Perforation, pericardial effusion, occlusion, and myocardial infarction were events listed as procedural and in hospital outcomes.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15844471
• MDR Text Key: 304114839
• Report Number: 2124215-2022-48474
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other