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

Model Number 3851

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.A visual examination identified that the balloon was not folded 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 media 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 media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure the balloon was inflated to its rate of burst pressure of 12 atmospheres using glycerol/water without issue.The inflation device was verified at 12 atmospheres, before and after use with a calibrated pressure gauge.No issues were identified with balloon the balloon material.A microscopic examination identified that one of the blades of the device had lifted approximately 1mm at the distal end.This type of damage is consistent with excessive force being applied to the device when encountering resistance.No issues or damage was noted to any of the other blades of the device.All other blades and blade pads remained fully bonded to the balloon material.A microscopic examination identified found the tip of the device to be damaged.This type of damage is consistent with excessive force being applied to the device when encountering resistance.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the hypotube was kinked at more than one location.No issues were noted which may have potentially contributed to the complaint incident.This type of damage is consistent with excessive force being applied to the device when encountering resistance.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 15jan2020.It was reported that the blade was deformed.The target lesion was located in a severely tortuous artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the blade appeared to be deformed due to inflation failure.The procedure was completed with another of the same device.No patient complications were reported and the patient was good post procedure.However, device analysis revealed that one of the blades was lifted from the balloon surface approximately 1mm at the distal end.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9683008
• MDR Text Key: 179472091
• Report Number: 2134265-2020-00915
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023919454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1