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

Model Number 3851

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/14/2021

Event Type  malfunction  

Event Description

It was reported that the blade was lifted.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During retrieval of the device, it was noted that the blade was lifted.The issue occurred due to the high-pressure dilation at 20 atmospheres.The device was completely removed from patient's body and the procedure was completed using this device.No patient complications were reported and there was no problem with the patient.

Event Description

It was reported that the blade was lifted.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During retrieval of the device, it was noted that the blade was lifted.The issue occurred due to the high-pressure dilation at 20 atmospheres.The device was completely removed from patient's body and the procedure was completed using this device.No patient complications were reported and there was no problem with the patient.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.All blades were present on the balloon surface however approximately 2mm of the distal end of a proximal segment of blade was lifted.The pad was intact with no damage noted.No damage was observed to the remaining blades.A visual and tactile examination found multiple kinking along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

• 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: 12562147
• MDR Text Key: 274274284
• Report Number: 2134265-2021-12233
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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 Expiration Date: 06/22/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027535527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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