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

Model Number H749CBM3300100

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the balloon was damaged.The target lesion was located in the right coronary artery.A 10/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon was damaged before it was inflated.When they pulled negative, blood was present in the inflation device.The procedure was completed with a different device.No patient complications were reported and the patient's condition was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6707523
• MDR Text Key: 79947947
• Report Number: 2134265-2017-06862
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/22/2017

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: 08/24/2018
• Device Model Number: H749CBM3300100
• Device Catalogue Number: CBM330010
• Device Lot Number: 0019632738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• 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