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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Event Description

It was reported that foreign matter was present.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention (pci) procedure.Upon removal of the device from the patient's body, a foreign matter described as a purple fragment was adhered to the device.The procedure was completed with a different device.No patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.The hypotube identified multiple kinks along the length of the device.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.The balloon material was unfolded which indicates its had been subjected to positive pressure.A visual and microscopic examination was performed on the balloon material and no damage or any issues were noted that could have contributed to the complaint incident.The tip of the device was intact and undamaged.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.The alleged foreign material was also received and inspected.The alleged fm was noted to be purple in colour.A visual and microscopic examination identified that the fm was most likely a tip of a medical device.There was evidence of stretching and breakage damage at the proximal end of the tip which indicates the tip detached from a different medical device.

Event Description

It was reported that foreign matter was present.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention (pci) procedure.Upon removal of the device from the patient's body, a foreign matter described as a purple fragment was adhered to the device.The procedure was completed with a different device.No patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.The hypotube identified multiple kinks along the length of the device.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.The balloon material was unfolded which indicates its had been subjected to positive pressure.A visual and microscopic examination was performed on the balloon material and no damage or any issues were noted that could have contributed to the complaint incident.The tip of the device was intact and undamaged.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.The alleged foreign material was also received and inspected.The alleged fm was noted to be purple in colour.A visual and microscopic examination identified that the fm was most likely a tip of a medical device.There was evidence of stretching and breakage damage at the proximal end of the tip which indicates the tip detached from a different medical device.Correction: evaluation conclusion codes - changed from - no problem detached - to - adverse event related to procedure.

Event Description

It was reported that foreign matter was present.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention (pci) procedure.Upon removal of the device from the patient's body, a foreign matter described as a purple fragment was adhered to the device.The procedure was completed with a different device.No patient complications reported.

• 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: 8182265
• MDR Text Key: 130999834
• Report Number: 2134265-2018-64060
• 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,Followup
• Report Date: 03/19/2019

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 Expiration Date: 09/30/2020
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0022727777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/28/2019; 02/25/2019
• Supplement Dates FDA Received: 02/25/2019; 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1