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

Model Number 3850

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter facility name: national hospital (b)(6).

Event Description

It was reported that the blade was lifted.The target lesion was located in a moderately tortuous and severely calcified mid right coronary artery.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the lesion was abraded with a 1.5mm rotablator burr.The wolverine device had been used several times when the blade was noted to be partially lifted.The procedure was completed, and the device was removed.No complications were reported, and the patient was in good condition.

Event Description

It was reported that the blade was lifted.The target lesion was located in a moderately tortuous and severely calcified mid right coronary artery.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the lesion was abraded with a 1.5mm rotablator burr.The wolverine device had been used several times when the blade was noted to be partially lifted.The procedure was completed, and the device was removed.No complications were reported, and the patient was in good condition.

Manufacturer Narrative

E1 initial reporter facility name: (b)(6) hospital h6 evaluation conclusion codes: corrected.

• 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: 18031045
• MDR Text Key: 326866444
• Report Number: 2124215-2023-60270
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0031505972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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