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

Model Number UNK145

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reportable based on analysis made on 08-may-2018.A 4.0/1.5/140 flextome cutting balloon was received with no reported issues.However, preliminary device analysis revealed a shaft break.

Manufacturer Narrative

Device updated by mfr.: the device was received in two separate pieces for analysis.One section consisted of hub/manifold and hypotube and the other section of hypotube, shaft and balloon.A visual and tactile examination identified a complete break approximately 173mm distal to the strain relief on the hypotube of the device.Multiple severe 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 may have contributed to the complaint incident.A visual and microscopic examination identified no damage to any of the blades.All blades were present and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.Oxidation was noted on the blades.The balloon was unfolded and solidified saline solution was noted within the balloon material which indicates it had been subjected to positive pressure.Due to the condition of the returned device is was not possible to inflate the balloon, however a full visual and microscopic examination identified no damage or any tears within the balloon material.No issues were noted with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the tip or markerbands of the device.No other issues were identified during the product analysis.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was further reported that the break was approximately 173mm distal to the strain relief.

• 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: 7569838
• MDR Text Key: 110119640
• Report Number: 2134265-2018-05487
• 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,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

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 Model Number: UNK145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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