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 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.A significant amount of blood was noted within the balloon material and lumens of the device.The balloon material was unfolded and blood was noted within the balloon material which indicates that the balloon had been subjected to positive pressure and also that a leak was present in the device.The investigator attached the device to an encore inflation unit and a positive pressure was applied in order to evaluate the balloon, however the balloon material failed to inflate and the pressure did not increase due to the presence of solidified blood within the device.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.On removal from the bath the investigator again attached the device to an encore inflation unit a positive pressure was applied, when blood and liquid was noted escaping from a hole in the shaft polymer extrusion of the device.This hole prevented liquid from reaching the balloon material.A visual and microscopic examination was performed on the balloon material and no damage or tears were noted, the investigator also submerged the balloon in water and palpated the balloon material to see if any bubbles could be seen, as bubbles would indicate a pinhole in the balloon material.No bubbles were noted during this analysis and no blood was noted within the water.No issues were noted with the balloon material.The hole in the shaft was noted to be at the location of a severe shaft kink 1170mm distal to strain relief, this hole may have been a result of a build up of pressure during inflation attempts underneath the severely damaged shaft material, resulting in the liquid perforating out through the shaft material.Multiple other severe kinks were also noted on the shaft polymer extrusion, this type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft polymer extrusion that could have contributed to the damage identified.A visual and microscopic examination identified no damage or any issues with the markerbands or blades of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and microscopic examination identified that the distal tip was damaged, this damage is consistent with excessive force being applied to the delivery device.No issues were noted with the tip that could have contributed to the damage identified.A visual and tactile examination identified multiple kinks along the length of the hypotube.This damage is consistent with excessive force being applied to the delivery device.No issues were noted with the hypotube that could have contributed to the damage identified.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 04oct2019.It was reported that the balloon pressure did not increase.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the pressure did not increase from the beginning and there was a blood that descended.The blood went into the indeflator through the balloon.The device was then simply pulled out from the patient's body.There were patient no complications and patient's condition was good.However, device analysis revealed that there was a hole on the shaft polymer extrusion.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9239664
• MDR Text Key: 167868619
• Report Number: 2134265-2019-12980
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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: 0024000456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2019
• 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