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 Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the catheter shaft broke.The target lesion was located in the severely calcified circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, after dilatation was performed with a bsc imaging catheter, it was noted that device was able to cross up to the midway of the lesion.A non-bsc guide extension catheter was used in combination.Furthermore, when the device was removed after deflation, resistance was met, so it was tried to expand again and removed, but it failed.After it was tried to remove again forcibly, it was noted that around 10cm of the shaft got separated from the tip of the device.Then, the section from the separated part to the tip was pulled out from the patient's body using a guiding catheter and guide extension in combination.The device was completely removed from the patient's body and the procedure was completed with the original device.No further complications were reported and the patient was good post procedure.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.The device was received in two sections as the result of a break in the shaft polymer extrusion.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 2mm 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 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.Blood was identified inside the balloon which is an indication of a device leak.The investigator was unable to inflate the balloon due to a detachment of the shaft of the device.A visual examination identified severe damage to the tip of the device.This type of damage is consistent with excessive force being applied to the device when attempting to cross the lesion.A visual and tactile examination found multiple severe kinks to the hypotube of the returned device.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination found the shaft polymer extrusion to be severely stretched and completely detached at the shaft polymer extrusion to hypotube bond.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified during the product analysis.

Event Description

It was reported that the catheter shaft broke.The target lesion was located in the severely calcified circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, after dilatation was performed with a bsc imaging catheter, it was noted that device was able to cross up to the midway of the lesion.A non-bsc guide extension catheter was used in combination.Furthermore, when the device was removed after deflation, resistance was met, so it was tried to expand again and removed, but it failed.After it was tried to remove again forcibly, it was noted that around 10cm of the shaft got separated from the tip of the device.Then, the section from the separated part to the tip was pulled out from the patient's body using a guiding catheter and guide extension in combination.The device was completely removed from the patient's body and the procedure was completed with the original device.No further complications were reported and the patient was good post procedure.It was further reported that there was a possibility that the blade was dislodged inside the guiding catheter when it was removed from the patient's body.

• 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: 9880239
• MDR Text Key: 187084892
• Report Number: 2134265-2020-03670
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024879720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE EXTENSION CATHETER - GUIDEPLUS2; GUIDE EXTENSION CATHETER - GUIDEPLUS2; IMAGING CATHETER - IMAGER; IMAGING CATHETER - IMAGER; INFLATION DEVICE - ENCORE; INFLATION DEVICE - ENCORE
• Patient Outcome(s): Required Intervention