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

Model Number 3822

Device Problem Failure to Advance (2524)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 31mar2022.It was reported that the balloon was unable to cross the lesion.The 95% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 15/2.75 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not pass through the lesion due to the lesion characteristics.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed 2 balloon pinholes located in the mid-body of the balloon.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic examination of the balloon found the wings to be in a deflated state and had been subjected to positive pressure.Blood was identified within the balloon and along the inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from 2 balloon pinholes located in the mid-body of the balloon.The balloon material, blades and marker bands of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination of the hypotube found no issues.No other issues were identified during the product analysis.

• 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: 13995641
• MDR Text Key: 288662066
• Report Number: 2134265-2022-03854
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P950020
• 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
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024833873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2019
• 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: 80 YR
• Patient Sex: Male