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

Model Number 3854

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2021

Event Type  Injury  

Event Description

It was reported that the balloon was stuck in the lesion and the tip broke off and remained inside the patient.The 95% stenosed target lesion was located in the severely tortuous and severely calcified mid coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated up to 10 atmospheres and the blades were deployed in the lesion.The balloon was fully deflated and, upon removal, it was noted that the device was stuck in lesion.The physician attempted to retract the balloon with great force at which point the tip broke off.The device was not able to be retrieved after several attempts.The procedure was completed by stenting the device and left it inside the body.No patient complications were reported.

Manufacturer Narrative

Corrected: h6 - device codes: initially reported (a0501)detachment of device or device component and corrected to (a0401)break.

Event Description

It was reported that the balloon was stuck in lesion, the tip broke off and was remained inside the patient.The 95% stenosed target lesion was located in the severely tortuous and severely calcified mid coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated up to 10 atmospheres and the blades were deployed in the lesion.Upon removal, the balloon was fully deflated and it was noted that the device was stuck in lesion.The physician attempted to retract the balloon with great force at which point the tip broke off.The device was not able to be retrieved after several attempts.The procedure was completed by stenting the device and left it inside the body.No patient complications were reported.It was further reported that the distal portion of the device including balloon/blades broke off.The balloon was fully deflated before attempting to pull the device back into the guidecather.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis and evaluation and the distal portion of the device included the balloon and blades was not returned for analysis.The shaft of the device was found to be separated at approx.24cm distal to the guidewire port.On the portion of the device that was returned, the following issues were noted: multiple hypotube kinks were present, mid shaft and the guidewire port region were found to be stretched.A blood like substance was visible inside the manifold region and along the inflation lumen.

Event Description

It was reported that the balloon was stuck in lesion, the tip broke off and was remained inside the patient.The 95% stenosed target lesion was located in the severely tortuous and severely calcified mid coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated up to 10 atmospheres and the blades were deployed in the lesion.Upon removal, the balloon was fully deflated and it was noted that the device was stuck in lesion.The physician attempted to retract the balloon with great force at which point the tip broke off.The device was not able to be retrieved after several attempts.The procedure was completed by stenting the device and left it inside the body.No patient complications were reported.It was further reported that the distal portion of the device including balloon/blades broke off.The balloon was fully deflated before attempting to pull the device back into the guide catheter.

• 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: 12522532
• MDR Text Key: 273098671
• Report Number: 2134265-2021-11796
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0025899291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention