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

Model Number 3824

Device Problem Failure to Advance (2524)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter facility name: (b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that there was blood present inside the balloon material.This is indicative of a device leak.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 found a perforation of the outer lumen at 13cm proximal to the proximal balloon cone.Stretch damage and flattening of the outer lumen was noted throughout the length of the shaft polymer extrusion.No other issues were identified with the returned device during the product analysis.

Event Description

Reportable based on device investigations completed on (b)(6) 2022.It was reported that crossing difficulties were encountered.The 32mmx2.5 mm, 90% stenosed target lesion was located in moderately tortuous and moderately calcified left circumflex artery.A 15/3.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion.The device was directly removed and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device investigation revealed that perforation of the outer lumen at 13cm proximal to the proximal balloon cone.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13945978
• MDR Text Key: 288366612
• Report Number: 2134265-2022-03256
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 3824
• Device Catalogue Number: 3824
• Device Lot Number: 0025304121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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