MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3822

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.The 87% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was advanced but failed to cross the lesion.During removal, significant resistance was encountered.The device was pulled to remove and the procedure was completed with another of the same device.There were no complications reported.

Event Description

It was reported that removal difficulties were encountered.The 87% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was advanced but failed to cross the lesion.During removal, significant resistance was encountered.The device was pulled to remove and the procedure was completed with another of the same device.There were no complications reported.

Manufacturer Narrative

The device was returned for analysis.A visual and microscopic examination identified no issues with the balloon.There were traces of contrast media present inside the balloon.No damage or any issues were noted with the balloon material or blades that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination of the shaft polymer extrusion identified no damages.A recommended 0.014 inch wire was inserted through wire lumen with no resistance.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14031097
• MDR Text Key: 288792097
• Report Number: 2134265-2022-03981
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024046324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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 Age: 68 YR
• Patient Sex: Male