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

Model Number 3851

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon became stuck in the lesion after deflation, the blade became detached and the detached fragment was pressed with a stent inside the patient's body.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, ablation was performed with 1.75mm rota, and inflation from rca mid to rca distal was done 7 to 8 times with this wolverine device.However, it was noted that the balloon became stuck after deflation, so the balloon was pulled out while repeating inflation and deflation.There was no issue noted upon deflation and the balloon was fully deflated.When the device was checked outside the patient's body, it was found that one blade became detached.It was confirmed with intravascular ultrasound (ivus) that the detached blade became stuck in the calcified lesion, so it was crimped to the blood vessel wall with a synergy stent.The procedure was not completed due to this event.No further patient complications were reported.

Manufacturer Narrative

A2 - age at time of event: 18 years or older.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination of the balloon identified no tears in the balloon material.The device was attached to an encore inflation unit and during an attempt to inflate the balloon, a pinhole leak was confirmed in the balloon material.The pinhole was located at the distal end of the distal markerband.A microscopic examination of the balloon and distal markerband identified no issues which could have resulted in the pinhole leak.Examinations did note that sections of blade were detached from the balloon.A detailed microscopic examination of the balloon and blades identified the following blade damage: damage noted on all three blades: blade 1 - blade lift noted at break point - no issues noted with blade pad.Blade 2 - blade lift noted at break point - no issues noted with blade pad.Blade 3 - main segment of the blade missing.Approximately 1mm of the proximal end of the blade and 1mm of the distal end of the blade was attached to the pad.The remaining section of blade was detached and was not returned for analysis.A microscopic examination identified no issue with the blade pad.A visual and tactile examination found no issues with the hypotube of this device.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.

Event Description

It was reported that the balloon became stuck in the lesion after deflation, the blade became detached and the detached fragment was pressed with a stent inside the patient's body.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, ablation was performed with 1.75mm rota, and inflation from rca mid to rca distal was done 7 to 8 times with this wolverine device.However, it was noted that the balloon became stuck after deflation, so the balloon was pulled out while repeating inflation and deflation.There was no issue noted upon deflation and the balloon was fully deflated.When the device was checked outside the patient's body, it was found that one blade became detached.It was confirmed with intravascular ultrasound (ivus) that the detached blade became stuck in the calcified lesion, so it was crimped to the blood vessel wall with a synergy stent.The procedure was not completed due to this event.No further patient complications were 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14584200
• MDR Text Key: 293252927
• Report Number: 2134265-2022-05991
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029207455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male