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

Model Number H749CBM3200060

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 year and above.(b)(4).

Event Description

It was reported that shaft detachment occurred.A 6mmx2mm flextome cutting balloon® was use to dilate the lesion.After the procedure when the device was removed from the patient, it was noted that balloon catheter was all torn apart and destroyed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The investigator observed that the hypotube was kinked in multiple locations.This type of damage is consistent with excessive force being applied to the delivery system when being handled.The midshaft was severely stretched and flattened along its entire length.This type of damage is consistent with excessive tensile force having been applied to the shaft.No damage was observed to the tip, blades or balloon.Then balloon folds were relaxed.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 shaft detachment occurred.A 6mmx2mm flextome® cutting balloon® was use to dilate the lesion.After the procedure when the device was removed from the patient, it was noted that balloon catheter was all torn apart and destroyed.No patient complications were reported.

• 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: 6145966
• MDR Text Key: 61465394
• Report Number: 2134265-2016-11001
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729808220
• UDI-Public: (01)08714729808220(17)20181119(10)0018657543
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2018
• Device Model Number: H749CBM3200060
• Device Catalogue Number: CBM320006
• Device Lot Number: 0018657543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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