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

Model Number 3854

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: the device was returned on (b)(6) and the date of event is approximated to be (b)(6) 2018.

Event Description

A 10 mm x 2.50 mm wolverine coronary cutting balloon monorail was returned.There was no device issue reported and no patient injury reported in relation to the device.However, returned device analysis completed on 03 august 2018 revealed a pin hole.Based on potential root causes identified, the following attributes were considered during analysis: a visual and microscopic examination was performed on the returned device.A visual examination identified that the balloon was unfolded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device and subjected to positive pressure however the balloon could still not be inflated due to the significant amount of solidified blood within the inflation lumen.A microscopic examination of the balloon material identified a pinhole in balloon material in the midpoint of the distal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.The rate of burst pressure of this wolverine device is 12 atm (atmospheres).The markerbands, blades and tip section of the device were visually and microscopically examined and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple 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 could have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

A 10 mm x 2.50 mm wolverine coronary cutting balloon monorail was returned.There was no device issue reported and no patient injury reported in relation to the device.However, returned device analysis completed on (b)(6) 2018 revealed a pin hole.Based on potential root causes identified, the following attributes were considered a visual and microscopic examination was performed on the returned device.A visual examination identified that the balloon was unfolded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device and subjected to positive pressure however the balloon could still not be inflated due to the significant amount of solidified blood within the inflation lumen.A microscopic examination of the balloon material identified a pinhole in balloon material in the midpoint of the distal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.The rate of burst pressure of this wolverine device is 12atm (atmospheres).The markerbands, blades and tip section of the device were visually and microscopically examined and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple 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 could have contributed to the complaint incident.No other issues were identified during the product analysis.It was previously reported that the device was a 10 mm x 2.50 mm wolverine coronary cutting balloon monorail, however the correct device size is 10 mm x 2.25 mm.

Manufacturer Narrative

Date of event was previously reported as (b)(6) 2018 and corrected to (b)(6) 2018.Was previously reported as 10 mm x 2.50 mm wolverine coronary cutting balloon and corrected to 10 mm x 2.25 mm wolverine coronary cutting balloon.Model number/catalog number was previously reported as 3851 and was corrected to 3854.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• 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: 7882036
• MDR Text Key: 120528715
• Report Number: 2134265-2018-61009
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

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 Model Number: 3854
• Device Catalogue Number: 3854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 09/28/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1