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

Model Number	H749CBO3300100
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the balloon would not retract back into the delivery sheath and the blade was partially lifted.The target lesion was located in the pulmonary vein.A 10/3.00 flextome® cutting balloon® cutting balloon was selected for use.During procedure, it was noted that the balloon would not retract back into the delivery sheath and the blade appeared to be bent and partially pulled away from the balloon.The whole system was then pulled out from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: device was returned for analysis.The balloon section, which was exposed from the sheath, was examined.There was a build-up of contrast media present inside the distal end of the balloon.The balloon material was creased.An examination of the blades found that the blades were intact.Due to the profile of the balloon, balloon not refolded with contrast media present inside, it was not possible to retract the balloon back through the sheath.As a result the balloon was pulled distally from the sheath in order to expose the full length of the balloon.An examination of the full length of the balloon found that the proximal section of the balloon material was tightly folded over the proximal markerband.It is most likely from the condition of the balloon that an attempt was made to withdraw the balloon back through the sheath before the balloon was fully deflated and/refolded.As a result just the proximal end of the balloon retracted back through the sheath and when the proximal end of the bladed section of the balloon met with the edge of the sheath, it could not withdraw any further.As part of the analysis, the balloon was inflated to its rated burst pressure of 12 atmospheres in order to better examine the balloon, blades and blade pads.The balloon inflated with no leaks noted.The inflation device was verified at 12 atmospheres before and after use with a calibrated pressure gauge.An examination confirmed that all blades and pads were intact.A vacuum was pulled and the balloon deflated fully with no resistance noted.When the balloon deflated without issue the balloon retracted fully through the sheath.The sheath was inspected and no damage was visible along the sheath.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 or Problem Description
It was reported that the balloon would not retract back into the delivery sheath and the blade was partially lifted.The target lesion was located in the pulmonary vein.A 10/3.00 flextome® cutting balloon® cutting balloon was selected for use.During procedure, it was noted that the balloon would not retract back into the delivery sheath and the blade appeared to be bent and partially pulled away from the balloon.The whole system was then pulled out from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7128103
• Report Number: 2134265-2017-12391
• Device Sequence Number: 13989398
• Product Code: NWX
• UDI-Device Identifier: 08714729808626
• UDI-Public: 08714729808626
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: H749CBO3300100
• Device Catalogue Number: CBO330010
• Device Lot Number: 0020288371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1