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

Model Number 3851

Device Problem Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Vascular Dissection (3160)

Event Date 04/10/2024

Event Type  Death  

Event Description

It was reported that the patient died.The 90% stenosed target lesion was located in the mildly tortuous left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon and 5.50mm x 12mm nc emerge were selected for use.During the procedure, a non-boston scientific ivus catheter advanced to view the proximal to middle left anterior descending artery, however, it was unable to cross the lesion.Then a wolverine was used but it was also unable to cross the lesion.While attempting to cross the lesion several times, dissection and perforation occurred in the left main trunk to the lad proximal with the guide wire, so the nc emerge balloon was used to treat it, but it could not stop the bleeding.The patient died.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: 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: 19175707
• MDR Text Key: 340964416
• Report Number: 2124215-2024-24701
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0032051404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IVUS CATHETER - PHILIPS
• Patient Outcome(s): Other; Death