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

Model Number	3854
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Corrected: h6 - device codes: initially reported (a0501)detachment of device or device component and corrected to (a0401)break.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2021-11796
• Device Sequence Number: 17198818
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 10/15/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/13/2021; 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention