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 Detachment of Device or Device Component (2907)

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

Event Date 03/02/2023

Event Type  Injury  

Event Description

It was reported that a tip fracture occurred.The 32mmx2.5mm in diameter, 85% stenosed target location was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the tip of the device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

Updated information based on additional information received.B1: adverse event and product problem should be selected if a product problem may have caused or contributed to the adverse event initially reported as product problem and updated to adverse event.H1: type of reportable event, initially reported as malfunction and updated to serious injury h6: impact codes, initially reported as no health consequences and updated to additional device required.Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination of the balloon found no tears or holes in the balloon material.No damage was observed to any of the blades.All blades are fully bonded onto the balloon.A visual and tactile examination found a kink at 69.9cm distal from the strain relief.A microscopic examination of the tip section of the device identified no damage.The tip was fully intact.Inserted a 0.014-inch wire through tip and wire lumen with no resistance noted.

Event Description

It was reported that a tip fracture occurred.The 32mmx2.5mm in diameter, 85% stenosed target location was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the tip of the device was fractured.The device was removed with a snare and the procedure was completed with another 10mmx2.50mm wolverine coronary cutting balloon.There were no complications reported and the patient was stable post procedure.

Event Description

It was reported that a tip fracture occurred.The 32mmx2.5mm in diameter, 85% stenosed target location was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the tip of the device was fractured.The device was removed with a snare and the procedure was completed with another 10mmx2.50mm wolverine coronary cutting balloon.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

Updated information based on additional information received.B1: adverse event and product problem should be selected if a product problem may have caused or contributed to the adverse event initially reported as product problem and updated to adverse event.H1: type of reportable event, initially reported as malfunction and updated to serious injury h6: impact codes, initially reported as no health consequences and updated to additional device required.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16629524
• MDR Text Key: 312232629
• Report Number: 2124215-2023-14492
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup
• Report Date: 06/06/2023

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: 0030486374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 03/29/2023; 05/19/2023
• Supplement Dates FDA Received: 04/12/2023; 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 67 KG