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); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that difficulty removing a catheter occurred, the cutting balloon blade broke and detached.The target lesion was located in the severely tortuous distal left circumflex (lcx).A 10 x 2.50mm wolverine¿ coronary cutting balloon¿ monorail¿ was used to perform dilation four to five times.Then dilation was performed with a 2.75 x 28mm non bsc device three times.A non bsc stent was implanted and optical frequency domain imaging was performed.Post dilation was performed several times with the wolverine at a maximum of 14 atmospheres.The wolverine was slightly withdrawn when it became stuck inside the proximal edge of the stent.A guidezilla 2 was inserted over the wolverine to give more support, but removal failed.Additional dilation was performed with approximately six balloons and a non bsc stent was placed in the proximal lcx and left main trunk (lmt) to left anterior descenting (lad) artery, the wolverine freed and was removed.It was noted that the mid portion of one blade was broken and detached, the location of the blade fragment is unknown.There were no patient symptoms after the procedure.

Manufacturer Narrative

Device evaluated by mfr: a visual and tactile examination identified multiple severe kinks along the length of the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that may have contributed to the complaint incident.A visual and microscopic examination was performed on the blades of the returned device.It was noted that one of the blades was damaged.Approximately 2mm of blade was noted to be lifted from the distal end of the balloon.The piece of detached blade was not returned for analysis.The remainder of the blade was intact and undamaged.The pad that the blade was attached to remains fully bonded to the balloon material.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.The two other blades and pads were undamaged and fully bonded to the balloon material.No issues were noted with either the blade or pad that could have contributed to the detachment from the balloon material.No other issues were noted with the blades of the returned device.The balloon was unfolded and solidified saline solution was noted within the balloon material which indicates it had been subjected to positive pressure.A visual and microscopic examination was performed on the returned balloon material and no tears or any damage was identified.No issues were noted that could have contributed to the complaint incident.A visual and tactile examination identified severe stretching damage along the shaft polymer extrusion of the device beginning approximately at the guidewire port and extending approximately 60mm proximately down the shaft.This type of damage is consistent with excessive tensile force being applied to the delivery system.No issues were noted with the shaft that may 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 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 the device was inflated over rated burst pressure.(b)(4).

Event Description

It was reported that difficulty removing a catheter occurred, the cutting balloon blade broke and detached.The target lesion was located in the severely tortuous distal left circumflex (lcx).A 10 x 2.50mm wolverine¿ coronary cutting balloon¿ monorail¿ was used to perform dilation four to five times.Then dilation was performed with a 2.75 x 28mm non bsc device three times.A non bsc stent was implanted and optical frequency domain imaging was performed.Post dilation was performed several times with the wolverine at a maximum of 14 atmospheres.The wolverine was slightly withdrawn when it became stuck inside the proximal edge of the stent.A guidezilla 2 was inserted over the wolverine to give more support, but removal failed.Additional dilation was performed with approximately six balloons and a non bsc stent was placed in the proximal lcx and left main trunk (lmt) to left anterior descenting (lad) artery, the wolverine freed and was removed.It was noted that the mid portion of one blade was broken and detached, the location of the blade fragment is unknown.There were no patient symptoms after the procedure.

• 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: 7594013
• MDR Text Key: 110844232
• Report Number: 2134265-2018-05130
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939403102500
• Device Catalogue Number: 39403-10250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ULTIMASTER STENT