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 Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Event date of (b)(6) 2021 is an estimate date based on the bsc aware date of (b)(6) 2021 as the exact event date was not reported.

Event Description

It was reported that the device was stuck in the lesion, and surgery was performed to remove the device.The 100% stenosed target lesion was located in a moderately tortuous and calcified right coronary artery (rca).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a procedure for st-elevation myocardial infarction (stemi).During the procedure, a flextome cutting balloon was initially used and worked normally, but had little effect on the lesion.Then a wolverine cutting balloon was used for vessel dilation.However, the wolverine become stuck in the calcium within the lesion.Removal attempts were made by placing another wire into the rca and inflating a non-bsc balloon near the wolverine with the intention of wedging the device free, which was unsuccessful.The patient was taken to the operating room and the wolverine device was removed.Patient was stable after the procedure and no complications reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11142678
• MDR Text Key: 226009700
• Report Number: 2134265-2021-00113
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2021

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 Expiration Date: 08/07/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025826243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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
• Patient Outcome(s): Required Intervention