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 Break (1069); Failure to Advance (2524)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that shaft break occurred.The de novo target lesion was located in the obtuse marginal branch.A 2.75 x 10mm wolverine cutting balloon was advanced but due to fibrocalcified plaque, the device would not cross the lesion.When the physician tried to negotiate, the shaft broke.The procedure was completed with a non compliant balloon.There were no complications reported and the patient condition following the procedure was stable.

Event Description

It was reported that shaft break occurred.The de novo target lesion was located in the obtuse marginal branch.A 2.75 x 10mm wolverine cutting balloon was advanced but due to fibrocalcified plaque, the device would not cross the lesion.When the physician tried to negotiate, the shaft broke.The procedure was completed with a non compliant balloon.There were no complications reported and the patient condition following the procedure was stable.It was further reported that the 80% to 90% stenosed target lesion was located in the moderately calcified and mildly tortuous obtuse marginal branch.The shaft fragment was retrieved by manually removing it from the guide.It was noted that a 6f guide catheter was used during the procedure.Significant resistance was encountered while navigating the device.

Manufacturer Narrative

A2 age at time of event: 18 years or older.Device evaluated by mfr: a 10mm x 2.75mm wolverine cutting balloon mr was returned for analysis.A visual examination identified that the balloon folds were wrapped.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination found that the device was received in two sections as a result of a break in the hypotube.The break was located at 20.9cm distal from the distal end of the strain relief.Hypotube kinks were also noted.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Manufacturer Narrative

A2 age at time of event: 18 years or older.

Event Description

It was reported that shaft break occurred.The de novo target lesion was located in the obtuse marginal branch.A 2.75 x 10mm wolverine cutting balloon was advanced but due to fibrocalcified plaque, the device would not cross the lesion.When the physician tried to negotiate, the shaft broke.The procedure was completed with a non compliant balloon.There were no complications reported and the patient condition following the procedure was stable.It was further reported that the 80% to 90% stenosed target lesion was located in the moderately calcified and mildly tortuous obtuse marginal branch.The shaft fragment was retrieved by manually removing it from the guide.It was noted that a 6f guide catheter was used during the procedure.Significant resistance was encountered while navigating the device.

• 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
• MDR Report Key: 12193386
• MDR Text Key: 262434610
• Report Number: 2134265-2021-09245
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027061248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1