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

Model Number 3822

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.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 blood that was present within the inflation lumen.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at the proximal end of the balloon.Microscopic analysis identified a 2 mm long hole/cut identified 1mm proximal of the proximal edge of the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.There are multiple kinks noted on the hypotube shaft.The most obvious kink is identified on the hypotube shaft approximately 40 mm distal from the distal edge of the strain relief.No other damage or any other issues were noted with the hypotube shaft that could have contributed to the complaint incident.A visual and tactile examination of the shaft polymer extrusion was completed.Multiple kinks were noted on the polymer extrusion shaft, this type of damage is consistent with excessive force being applied to the delivery system.There were no other issues with the polymer extrusion shaft of the device.All blades were intact and fully bonded to the balloon surface.No damage or any issues were noted with the blades that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands was completed.There was no burrs or uneven edges observed on the markerbands.No damage or any issues were noted with the markerbands that could have contributed to the complaint incident.No damage or any issues were noted with the tip that could have contributed to the complaint incident.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that the device could not cross the lesion.The 80% stenosed, 32x3.0mm target lesion was located in a severely tortuous and moderately calcified left circumflex artery (lcx).A 10/2.50 flextome cutting balloon was selected for use.During the procedure, it was noted that the device was unable to cross the lesion.The procedure was completed with another of the same device.No complications reported and the patient's condition was stable.However, device analysis revealed that the device was leaking due to a balloon pinhole located at the proximal end of the balloon.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9104379
• MDR Text Key: 159611903
• Report Number: 2134265-2019-11528
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0022991449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• 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 Age: 65 YR