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

Model Number 3822

Device Problems Leak/Splash (1354); Failure to Advance (2524)

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

Event Date 04/17/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).The device was returned for evaluation.A visual examination identified that the balloon was in a relaxed state with evidence of solidified blood inside the balloon material.The device was placed in the water bath at 37 degrees to allow the solidified blood inside the balloon body to soften to aid an inflation attempt.The device was attached to encore inflation device and during an attempt to inflate the balloon, a balloon pinhole leak was confirmed over the proximal markerband.A visual and microscopic examination observed no damage to the markerbands, tip or blades.All blades were present and fully bonded to the balloon surface.No damage or any issues were noted with the markerbands, blades or tip that could have contributed to the complaint incident.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination found that there were no issues with the extrusion shaft.No other issues were identified with the returned device during the product analysis.

Event Description

Reportable based on device analysis completed on 25jun2021.It was reported that crossing difficulties and balloon leak occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery which included a significant bend.A 10/3.25 flextome cutting balloon was selected for use.During the procedure, the balloon could not cross the lesion.The balloon was inflated once at 6 atmospheres and a leak was noted.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed a balloon pinhole.

• 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: 12142559
• MDR Text Key: 260709751
• Report Number: 2134265-2021-08776
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021

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: 10/22/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024644899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2019
• 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: 66 YR
• Patient Weight: 76