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

Model Number H749RB4350100

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

Patient Problem Intimal Dissection (1333)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).

Event Description

It was reported that a blade detachment and vessel dissection occurred.The 90% stenosed target lesion was located in a moderately tortuous and mildly calcified proximal right coronary artery (rca).A 10/3.50 flextome¿ cutting balloon¿ was used for pre-dilatation.During the procedure, resistance was observed when the device was retracted into a non bsc guiding catheter after the second inflation.The device was then pushed into the vessel once and was then removed from the patient's body.However, it was noted that a part of the blade was detached and the distal tip of the guiding catheter was torn.Dissection of the ostial of the rca was also noted.A 4.0/12 promus premier stent was then deployed to the area of dissection.No further patient complications were reported and the patient's condition was good.

Manufacturer Narrative

The device was returned for evaluation.Visual examination of the device observed that approximately 2mm of the proximal end of a distal blade had detached from the balloon's body.The blade pad was still intact.The remaining blades were fully bonded to the balloon and no damage was noted to the other blades.A visual and microscopic examination observed no damage to the tip.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was connected to an inflation device and a vacuum was pulled for balloon preparation prior to advancement through the recommended guide catheter as identified on the product label.The device was passed over a 0.014 inch guidewire and advanced through a 6f guide catheter without issue.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole at the distal edge of the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.The device was removed through the 6f guide catheter with no resistance encountered.No kinks or damage were noticed along the shaft of the device; however, during analysis, the midshaft became kinked at the guidewire exit port during insertion through the guide catheter.No other issues were noted during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a blade detachment and vessel dissection occurred.The 90% stenosed target lesion was located in a moderately tortuous and mildly calcified proximal right coronary artery (rca).A 10/3.50 flextome cutting balloon was used for pre-dilatation.During the procedure, resistance was observed when the device was retracted into a non bsc guiding catheter after the second inflation.The device was then pushed into the vessel once and was then removed from the patient's body.However, it was noted that a part of the blade was detached and the distal tip of the guiding catheter was torn.Dissection of the ostial of the rca was also noted.A 4.0/12 promus premier stent was then deployed to the area of dissection.No further patient complications were reported and the patient's condition was good.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5131411
• MDR Text Key: 27770006
• Report Number: 2134265-2015-06688
• 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: Physician
• Type of Report: Followup
• Report Date: 09/10/2015

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 Expiration Date: 01/23/2017
• Device Model Number: H749RB4350100
• Device Catalogue Number: RB435010
• Device Lot Number: 16685729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2014
• 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): Required Intervention