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

Model Number 3850

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported that blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery.A 6mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, balloon was inflated up to 12 atm and 15 dilations were made to the lesion, but sufficient inflation was not achieved.The balloon was retrieved and upon checking, all the blades had detached.Ivus was performed and the detached blade was not confirmed to be within the patient.The procedure was terminated due to sufficient dilation had not been obtained.No patient complications were reported.

Event Description

It was reported that blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery.A 6mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, balloon was inflated up to 12 atm and 15 dilations were made to the lesion, but sufficient inflation was not achieved.The balloon was retrieved and upon checking, all the blades had detached.Ivus was performed and the detached blade was not confirmed to be within the patient.The procedure was terminated due to sufficient dilation had not been obtained.No patient complications were reported.It was further reported that the blades remained inside the patient.The lesion was not sufficiently expand even though it was inflated 15 times, therefore no further treatment was performed.

Manufacturer Narrative

Updated h6 patient codes from no clinical signs, symptoms or conditions to foreign body in patient based on additional information received.Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.All 3 blades had detached from the balloon and were not returned with the device.A detailed microscopic examination confirmed that the 3 blade castpads were fully intact.All of the blade tangs were still bonded to the balloon which indicates that the blades had been securely bonded at the time of manufacture, on the balloon surface.A visual and tactile examination found no damages on the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure per ifu of 12 atmospheres.No leaks were confirmed.The inflation device verified before and after use using a druck pressure gauge.No other issues were identified during the product analysis.

Manufacturer Narrative

Updated h6 patient codes from no clinical signs, symptoms or conditions to foreign body in patient based on additional information received.

Event Description

It was reported that blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery.A 6mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, balloon was inflated up to 12 atm and 15 dilations were made to the lesion, but sufficient inflation was not achieved.The balloon was retrieved and upon checking, all the blades had detached.Ivus was performed and the detached blade was not confirmed to be within the patient.The procedure was terminated due to sufficient dilation had not been obtained.No patient complications were reported.It was further reported that the blades remained inside the patient.The lesion was not sufficiently expand even though it was inflated 15 times, therefore no further treatment was performed.

• 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: 16247687
• MDR Text Key: 308358162
• Report Number: 2124215-2023-02581
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2023

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
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0029942936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 01/30/2023; 03/08/2023
• Supplement Dates FDA Received: 02/15/2023; 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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): Other