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

Model Number 3822

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

It was reported that the balloon was lifted up.A 10/2.75 flextome cutting balloon was selected for use.During preparation, it was noticed that the surface of the device was not smooth as the balloon was lifted up.No patient complications were reported and the device did not enter the patient's body.The procedure was completed with a different device.The patient was stable post procedure.

Event Description

It was reported that the balloon was lifted up.A 10/2.75 flextome cutting balloon was selected for use.During preparation, it was noticed that the surface of the device was not smooth as the balloon was lifted up.No patient complications were reported and the device did not enter the patient's body.The procedure was completed with a different device.The patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to a boston scientific encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12atm (atmospheres) without issue.A vacuum was then applied.The inflation device was verified at 12atm (atmospheres), before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 12atm was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual and microscopic examination found no issue with the markerbands.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.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
• MDR Report Key: 8808001
• MDR Text Key: 151608663
• Report Number: 2134265-2019-08476
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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: 02/04/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0023298100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 71