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

Model Number 3852

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that a blade detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.A 15 mm x 3.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, an inflation of the device at the lesion site was performed.However, when withdrawing the balloon, damage to the blade was noted when the device was recovered from the artery.The 15 mm long wolverine blade was detached.All the blades were removed from the patient's body.As per the physician, there was a possibility that the device interfered with the tip of the guiding catheter during removal.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual and tactile inspections and a microscopic analysis was performed.A microscopic examination of the blade segments identified approximately 4mm of a proximal blade and pad segment was raised off the balloon.All other blades were fully bonded onto the balloon.No blade segment had detached from the balloon.The raised proximal blade segment was still attached.No other damage was identified along the entire device.

Event Description

It was reported that a blade detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.A 15 mm x 3.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, an inflation of the device at the lesion site was performed.However, when withdrawing the balloon, damage to the blade was noted when the device was recovered from the artery.The 15 mm long wolverine blade was detached.All the blades were removed from the patient's body.As per the physician, there was a possibility that the device interfered with the tip of the guiding catheter during removal.No patient complications were 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; 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: 18655293
• MDR Text Key: 334787854
• Report Number: 2124215-2024-02716
• 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,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0032126580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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