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

Model Number 3822

Device Problems Break (1069); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received in two sections as a result of a break in the hypotube.A visual and tactile examination identified a complete break in the hypotube of the device.The break was located at 255 mm distal to the strain relief.The hypotube was also kinked at more than one location.No other issues were noted with the hypotube that may have contributed to the complaint incident.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Due to the condition of the returned device it was not possible to inflate the balloon in the normal fashion, due to the break in the hypotube.As a result, an inflation aid was attached to the distal section of the hypotube break.This facilitated the connection of the encore inflation unit which allowed the balloon to be inflated.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure (rbp) without issue.A vacuum was then applied.The inflation device was verified at the rbp, before and after use with a pressure gauge.This inflation to rate of burst pressure 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 identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.

Event Description

Reportable based on additional information received on 30 may 2019.It was reported that the balloon would not dilate.A 10/2.75 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon could not dilate.The procedure was not completed due to the issue.No complications reported and the patient's condition is stable.It was further reported that the hypotube broke.

• 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: 8731367
• MDR Text Key: 149097413
• Report Number: 2134265-2019-07352
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0022783585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2018
• 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: 30 YR
• Patient Weight: 110