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 Problem Embolism/Embolus (4438)

Event Date 07/09/2022

Event Type  Injury  

Manufacturer Narrative

Matsukawa, r., matsuura, h., tokutome, m., okahara, a., hara, a., okabe, k., kawai, s., & mukai, y.(2022).Use of a cutting balloon reduces the incidence of distal embolism in acute coronary syndrome requiring predilatation before stenting.Circulation reports, 4(8), 345-352.Https://doi.Org/10.1253/circrep.Cr-22-0056.

Event Description

It was reported via journal article that distal embolism occurred.This study utilized pseudo-thrombus in an ex vivo experimental model to compare thrombus dispersal using a cutting balloon and non-compliant balloon.There were no patients involved in this model.The pseudo-thrombus lesions were dilated with either a cutting balloon (wolverine 3.0x10mm, 6atm) or a non-compliant balloon (emerge 3.0x12mm, at 12atm) for 10 seconds each.The weight of the pseudo-thrombus model was measured before and after dilatation.The difference in weight from before to after balloon dilatation was divided by the original weight to obtain the pseudo-thrombus dispersal rate.Pseudo-thrombus dispersal, regarded as an index of distal emboli, was lower in the cutting balloon than the non-compliant balloon.

• 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; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15896590
• MDR Text Key: 304633779
• Report Number: 2124215-2022-50261
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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