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

Model Number H74939403102500

Device Problems Break (1069); Detachment Of Device Component (1104); Peeled/Delaminated (1454)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that blade lifting and blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).Various devices were unable to cross due to the severe calcification.A non-bsc balloon catheter ruptured.Dilation was performed with a 2.75mm non-bsc balloon catheter.A 2.5 x 6mm flextome balloon catheter was unable to cross the lesion.Then a 10mm x 2.50mm wolverine¿ coronary cutting balloon¿ monorail¿ was advanced, however, it was unable to cross the distal rca.The physician inserted a guidezilla 2 into the mid rca then the wolverine device was inserted into guidezilla 2 and the wolverine could be advanced to the distal rca.The wolverine was expanded in the distal of rca approximately 20 times for a total of 515 seconds.The physician performed an ¿anchor balloon technique¿ where the wolverine was manipulated back and forth in the blood vessel, in the expanded state.Two stents were placed and the procedure was completed.Imaging was performed and after the procedure, the wolverine was examined and one of the three blades was found lifted and one blade was detached in half and missing.There is possibility of a blade fragment left inside the patient's body.The patient¿s condition is progressing well.

Event Description

It was reported that blade lifting and blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).Various devices were unable to cross due to the severe calcification.A non-bsc balloon catheter ruptured.Dilation was performed with a 2.75mm non-bsc balloon catheter.A 2.5 x 6mm flextome balloon catheter was unable to cross the lesion.Then a 10mm x 2.50mm wolverine¿ coronary cutting balloon¿ monorail¿ was advanced, however, it was unable to cross the distal rca.The physician inserted a guidezilla 2 into the mid rca then the wolverine device was inserted into guidezilla 2 and the wolverine could be advanced to the distal rca.The wolverine was expanded in the distal of rca approximately 20 times for a total of 515 seconds.The physician performed an ¿anchor balloon technique¿ where the wolverine was manipulated back and forth in the blood vessel, in the expanded state.Two stents were placed and the procedure was completed.Imaging was performed and after the procedure, the wolverine was examined and one of the three blades was found lifted and one blade was detached in half and missing.There is possibility of a blade fragment left inside the patient's body.The patient¿s condition is progressing well.

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: the wolverine device was received and analyzed.A thorough visual and microscopic examination was performed on the blades of the returned device.It was noted that two of the blades were damaged.A section of one blade approximately 5mm in length was noted to be completely detached from the balloon material.The blade detached distally from the midpoint of the balloon.The pad was intact and the remainder of the blade undamaged and fully bonded to the balloon material.The blade tab was intact and still attached to the balloon material.A second blade was also noted to be damaged with approximately 2mm of blade lifted distally from the balloon material.The pad and blade tab were intact and the remainder of the bade undamaged and fully attached to the balloon material.The third blade was undamaged and fully bonded to the balloon material.The damage could potentially be a result of the resistance encountered during the advancement or withdrawal of the device, however after examination of the blades the damage must have occurred during advancement.No issues were noted with either the blade or pad that could have contributed to the detachment from the balloon material.A visual and microscopic examination was performed on the returned balloon material.The balloon material was unfolded and solidified saline solution was noted within the balloon material 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 could not be inflated due to the presence of solidified saline solution within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified blood before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied.The balloon successfully inflated to its rate of burst pressure of 12 atmospheres.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.It was reported that this wolverine device was used as an anchor balloon during this procedure.The directions for use state: ¿¿the wolverine cutting balloon device is indicated for use in patients with coronary vessel disease who are acceptable candidates for coronary artery bypass graft surgery, should it be urgently needed, for the purpose of improving myocardial perfusion.When the device is inflated, the atherotomes score the plaque, creating initiation sites or crack propagation.This process, referred to as atherotomy, allows dilatation of the target lesion with less pressure.'' (b)(4).

• Brand Name: WOLVERINE¿ CORONARY CUTTING BALLOON¿ MONORAIL¿
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7513821
• MDR Text Key: 108237784
• Report Number: 2134265-2018-03947
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020/S072
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2020
• Device Model Number: H74939403102500
• Device Catalogue Number: 39403-10250
• Device Lot Number: 21667960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other