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

Model Number H749RB4400150

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a catheter detachment occurred.A 4.00mm x 15mm flextome¿ cutting balloon¿ was selected for use.During unpacking, it was noted that the distal part of the device was detached.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received in two sections due to a break in the extrusion.An examination of the returned device found a break in the shaft polymer extrusion at the guidewire exit port.The balloon protector was still attached to the balloon.Further evaluation of the break site found that the extrusion was stretched at the site of the break.This type of damage is consistent with excessive force being applied to the delivery system during the removal of the balloon protector.The hypotube was kinked at various locations along its length.A kink was also observed in the distal extrusion at 18cm distal to the port site.The kinks observed along the shaft are consistent with excessive forces having been applied to the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that a catheter detachment occurred.A 4.00mm x 15mm flextome¿ cutting balloon¿ was selected for use.During unpacking, it was noted that the distal part of the device was detached.No patient complications were reported and the patient status was stable.

• 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: 6189535
• MDR Text Key: 62857104
• Report Number: 2134265-2016-12117
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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: 10/11/2018
• Device Model Number: H749RB4400150
• Device Catalogue Number: RB440015
• Device Lot Number: 18504131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• 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