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 Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.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 subjected to positive pressure and liquid was observed to be leaking from a longitudinal tear detected 1mm proximal of the proximal markerband stretching for 9mm towards the middle of the balloon material.The rated burst pressure for this device is not to exceed 12atm as referenced in the product specification.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No damage or any issues were noted with the polymer extrusion shaft that could have contributed to the complaint incident.A visual and tactile examination of the hypotube was completed.No damage or any issues were noted with the hypotube that could have contributed to the complaint incident.No damage or any issues were noted with the tip or markerbands that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.No other issues were noted during analysis.

Event Description

Reportable based on device analysis completed on 21nov2019.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, when the balloon was inflated, it was noted that the proximal side did not expand.Although pressure was applied up to the rated pressure, still inflation failure occurred.The procedure was completed with the original device.There were no complications reported.However, device analysis revealed that liquid was observed to be leaking from a longitudinal tear in the balloon.

• 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: 9444407
• MDR Text Key: 176040476
• Report Number: 2134265-2019-15273
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023435819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• 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