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

Model Number H749CBO3400100

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the device was difficult to remove and an embolism occurred.A flextome cutting balloon was being used in the pulmonary vein.After inflation, the balloon was unable to be pulled back into the delivery sheath and blades lifted.It was unknown if the balloon rewrapped properly or if the balloon was unable to deflate completely.The device was removed from the patient along with the guide catheter system in tandem.The procedure was completed.It was further reported a thrombotic event occurred.This was perceived to have been caused by the equipment being stagnant within vessel the patient was reported to be fine post procedure.Additional information has been requested but has not been able to be obtained.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the balloon was unfolded which indicates it had been subjected to positive pressure.A significant amount of hardened saline solution was also noted within the balloon material.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified saline solution present within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified saline solution present before further inflation attempts were made.The device was removed from the bath and the device was again attached to an encore inflation unit filled with glycerol/h2o solution and positive pressure applied.The balloon was successfully inflated to its rate of burst pressure of 12atm (atmospheres).The inflation device was verified at 12 atmospheres before and after use with a calibrated pressure gauge.Using the same encore, a vacuum was pulled and the balloon successfully deflated in 17 seconds.This inflate to rated burst pressure and deflation fully under vacuum was repeated on three more occasions and on each occasion the balloon deflated fully in an average time of 17seconds.No issues were noted with the refolding ability of the balloon material.No issues were noted with the balloon material that could have contributed to the complaint incident.A visual examination of the device noted that one of the blades was partially detached and lifted from the balloon material.Additional microscopic analysis identified that approximately 5mm of blade was detached from the proximal end of the balloon material, the distal end of this damaged section of blade was maintaining the connection between the blade and balloon material.The next section of blade approximately 1mm in length was noted to be lifted from the balloon material.Approximately 3mm of the blade was left fully attached to the balloon material and undamaged.The pad was undamaged and fully attached to the balloon material.This damage can potentially be the result of resistance being encountered during advancement or withdrawal of the device.All other blades were present and fully bonded to the balloon material.No issues were noted with the blade or pad that could have contributed to the complaint incident.A visual and tactile inspection identified one severe shaft kink 615mm distal to the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.No damage was observed to the tip or markerbands of the device which could potentially have contributed to this complaint incident.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported the device was difficult to remove and an embolism occurred.A flextome cutting balloon was being used in the pulmonary vein.After inflation the balloon was unable to be pulled back into the delivery sheath and blades lifted.It was unknown if the balloon rewrapped properly or if the balloon was unable to deflate completely.The device was removed from the patient along with the guide catheter system in tandem.The procedure was completed.It was further reported a thrombotic event occurred.This was perceived to have been caused by the equipment being stagnant within vessel the patient was reported to be fine post procedure.Additional information has been requested but has not been able to be obtained.

• 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: 7122789
• MDR Text Key: 95047146
• Report Number: 2134265-2017-12408
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729808664
• UDI-Public: 08714729808664
• 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,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749CBO3400100
• Device Catalogue Number: CBO340010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/14/2018
• 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
• Patient Outcome(s): Other