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 Material Rupture (1546); Failure to Advance (2524)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, this device was brought in, but it was unable to cross due to the severe calcification.Therefore, pre-dilation was performed with a 1.5 mm balloon.Subsequently, this device was used again to dilate the lesion, however, this was determined to be a rupture as pressure was lost.A pinhole rupture on the distal side, around the shoulder was noted.The device removed from the patient's body without any problem using the normal method and usage was discontinued.The procedure was completed with a different device.No complications reported and patient was in good condition post procedure.

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) medical center.Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon wings were in a deflated state and had been subjected to positive pressure.There was a large build-up of solidified blood inside the balloon.A microscopic examination of the balloon found no tears or holes in the balloon material.The device was attached to a boston scientific encore inflation unit and during an attempt to inflate the balloon a pinhole leak confirmed.The pinhole leak was confirmed over the distal edge of the proximal markerband.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found no kinks along the length of the hypotube.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, this device was brought in, but it was unable to cross due to the severe calcification.Therefore, pre-dilation was performed with a 1.5 mm balloon.Subsequently, this device was used again to dilate the lesion, however, this was determined to be a rupture as pressure was lost.A pinhole rupture on the distal side, around the shoulder was noted.The device removed from the patient's body without any problem using the normal method and usage was discontinued.The procedure was completed with a different device.No complications reported and patient was in good condition post procedure.

• 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: 16460701
• MDR Text Key: 310437201
• Report Number: 2124215-2023-09522
• 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: 04/20/2023

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: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0029673464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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