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

Model Number 3824

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination of the returned device identified a severe kink in the hypotube.The kink was located at 64.5cm distal to the strain relief.This kink is consistent with excessive force having been applied to the shaft.An examination of the balloon found traces of blood inside the balloon.This blood is consistent with a leak in the balloon.All blades were fully bonded on the balloon and an examination of the balloon material identified no tears.The device was attached to an encore inflation device and during an attempt to inflate the balloon a pinhole leak was confirmed at the proximal edge of the distal markerband.No issues were identified with the balloon which could contribute to a pinhole leak.An examination of the distal markerband identified no damage.No other issues were identified with the device.

Event Description

Reportable based on device analysis completed on 26jul2019.It was reported that the catheter could not be recognized by the system.The target lesion was located in the right coronary artery.A 15/3.00 flextome cutting balloon was selected for use.During the procedure, the device could not be recognied by the system and motor.The procedure was completed with another of the same device.No complications were reported and patient status was stable.However, device analysis revealed pinhole leak at the proximal edge of the distal markerband.

• 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: 8906750
• MDR Text Key: 154749765
• Report Number: 2134265-2019-09832
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P950020
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 3824
• Device Catalogue Number: 3824
• Device Lot Number: 0023109756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• 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 Weight: 55