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

Model Number 3824

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.A visual and microscopic examination of the balloon, blade, merkerbands, hypotube and shaft.The balloon noted that the balloon was tightly folded and had not been subjected to positive pressure.No issues were identified with the balloon material that could have contributed to the complaint incident.Blades noted that all blades were present and fully bonded to the balloon material.No damage or any issues were noted with the blades that could have contributed to the complaint incident.No issues were observed with the tip or markerbands.It was noted that the break in the hypotube was approximately 1420mm proximal to the tip.The detached section of hypotube and manifold were not returned for analysis.Multiple kinks were also noted along the length of the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that could have contributed to the damage identified.An approximate 6mm kinked was noted proximal to the proximal markerband on the saft polymer extrusion.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the product analysis.

Event Description

Reportable based on new information received on (b)(6) 2019.It was reported that difficulty crossing lesion occurred.The target lesion was located in the left coronary artery.A 15/3.00 flextome cutting balloon was selected for use.During procedure, it was noted that the device could not cross the lesion.The procedure was completed using a different device of the same.No patient complications were reported.However, additional information revealed that the device was returned with a broken hypotube and the manifold completely detached.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8400109
• MDR Text Key: 138122779
• Report Number: 2134265-2019-02188
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: 3824
• Device Catalogue Number: 3824
• Device Lot Number: 0022175003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2018
• 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: 58 YR
• Patient Weight: 77