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 Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

It was noted that the atherotome was detached from the balloon.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the physician took the device to the guiding catheter to change the atherotome position, it was noted that the atherotome got detached from the balloon.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was noted that the atherotome was detached from the balloon.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the physician took the device to the guiding catheter to change the atherotome position, it was noted that the atherotome got detached from the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was completely removed from the patient without any further intervention.

Event Description

It was noted that the atherotome was detached from the balloon.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the physician took the device to the guiding catheter to change the atherotome position, it was noted that the atherotome got detached from the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was completely removed from the patient without any further intervention.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual, tactile, microscopic inspection and leakage testing was performed.There were no issues identified with the hypotube shaft, and no kinks or damages were identified on shaft polymer extrusion.A visual examination of the balloon identified no damages.No issues identified during microscopic examination of the extrusion shaft.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A microscopic examination of the blades identified that one entire blade segment (apart from the distal tang) had detached from the balloon.The actual pad was fully intact on the balloon.No other damage was observed to the remaining blade segments or pads.The blade segment was not present in the packaging for this device when presented for analysis.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.As part of the device analysis, the device was attached to a pretested encore inflation unit and the balloon was inflated to its rated burst pressure of 12 atmospheres with no leaks noted in the balloon.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17105768
• MDR Text Key: 317035532
• Report Number: 2124215-2023-27936
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030810857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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