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 Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that a blade lifted.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).After ablation was performed with a 1.5 mm rotablator, a 10 mm x 2.75 mm wolverine coronary cutting balloon monorail was used to dilate the target lesion in combination with a guidezilla ii.The wolverine was inflated to its maximum, 12 atmospheres 5 times.A larger 1.75 mm rotablator was used after checking the intravascular ultrasound (ivus).The lesion was then dilated using the wolverine at a maximum 12 atmospheres for 5 times.The procedure was completed after confirming the dilatation of the lesion area with ivus.After completing the procedure, the wolverine was checked outside the patient body and it was noticed that the bonding on the proximal side of one blade was lifted and was about to break or separate.No patient complications were reported in relation to this event.

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter facility name: (b)(6).Device evaluated by mfr: the wolverine device was received and analyzed.A section of one of the blades and pads was returned lifted from the balloon material.A visual and microscopic examination was performed on the blades of the returned device.It was noted that approximately 5mm of one of the blades and pads was lifted from the proximal end of the balloon material, the remaining 5mm of blade and pad was intact an undamaged.This damage is consistent with resistance encountered during removal of the device.All other blades were intact and undamaged.No issues were noted with the blades or pads that could have contributed to the damage identified.A visual and tactile examination identified multiple kinks along the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotbe that may have contributed to the complaint incident.A visual and microscopic examination was performed on the returned balloon material.The balloon material was returned unfolded which indicates the balloon had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied.The balloon was successfully inflated to its rate of burst pressure of 12atm (atmospheres) with no issues noted.The inflation device was verified at 12atm (atmospheres), before and after use with a calibrated pressure gauge.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the tip or markerbands of the device.No other issues were identified during the product analysis.

Event Description

It was reported that a blade lifted.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).After ablation was performed with a 1.5 mm rotablator, a 10 mm x 2.75 mm wolverine coronary cutting balloon monorail was used to dilate the target lesion in combination with a guidezilla ii.The wolverine was inflated to its maximum, 12 atmospheres 5 times.A larger 1.75 mm rotablator was used after checking the intravascular ultrasound (ivus).The lesion was then dilated using the wolverine at a maximum 12 atmospheres for 5 times.The procedure was completed after confirming the dilatation of the lesion area with ivus.After completing the procedure, the wolverine was checked outside the patient body and it was noticed that the bonding on the proximal side of one blade was lifted and was about to break or separate.No patient complications were reported in relation to this event.

• 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: 8317488
• MDR Text Key: 135431425
• Report Number: 2134265-2019-00904
• 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
• Report Date: 03/26/2019

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: 11/04/2020
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0022894347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEZILLA II; GUIDEZILLA II; ROTABLATOR; ROTABLATOR; GUIDEZILLA II; ROTABLATOR