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 Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon was stuck in the lesion.The target lesion was located in the left main trunk to proximal left circumflex artery.A 10mmx2.25mm wolverine coronary cutting balloon was inflated gradually up to the maximum of 12atm but became stuck and could not be removed even after deflation.A non bsc balloon was inserted to change the contact.The wolverine was released and removed intact to complete the procedure.No patient complications were reported and patient was good post procedure.

Event Description

It was reported that the balloon was stuck in the lesion.The target lesion was located in the left main trunk to proximal left circumflex artery.A 10mmx2.25mm wolverine coronary cutting balloon was inflated gradually up to the maximum of 12atm but became stuck and could not be removed even after deflation.A non bsc balloon was inserted to change the contact.The wolverine was released and removed intact to complete the procedure.No patient complications were reported and patient was good post procedure.It was further reported that a non-bsc stent was placed in the left main trunk to mid left anterior descending area.Starting from the proximal of distal left circumflex (lcx) to left main trunk area, dilation was performed by inflating the wolverine balloon repeatedly.When the wolverine balloon was inflated in the tortuous bifurcation area through the stent struts from left main trunk to proximal lcx, the wolverine became stuck.Subsequently, a non-bsc balloon catheter was used with the anchor balloon technique but failed to release the wolverine.The two wire technique was then used with a non-bsc wire in the proximal lcx and then a balloon catheter was advanced to release the stuck wolverine balloon.It was noted that the blade was damaged when the device was removed from the patient which was thought to have occurred at the tortuous area.It is unknown if any part of the blades detached inside the patient and where inside the patient.It was additionally noted that the blade damage was noticed outside the patient's body but the blade might have been damaged when they removed the blood from the blade using a brush.No further patient complications were reported.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 3mm in length was completely detached from the proximal end of the balloon material.The remaining section of blade was undamaged and fully bonded to the balloon material.The complete pad of the blade remained fully bonded to the balloon material.The detached section of blade was not returned for analysis.The damage identified can potentially be a result of the resistance encountered during withdrawal of the device.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A boston scientific encore inflation device was attached, and the device was inflated to its rated burst pressure of 12 atmospheres without any issues experienced.A microscopic examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual examination identified no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the hypotube of the returned device.No other issues were identified during the product analysis.Corrections: b1 adverse event/product problem: product problem to adverse event and product problem.B2 outcomes attrib to adv event: required intervention to permanent impairment/damage.

• 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: 9583328
• MDR Text Key: 175024874
• Report Number: 2134265-2019-16451
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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 Expiration Date: 09/15/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024434093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention