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

Model Number H749CBM3350150

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported that a balloon pinhole occurred.The target lesion was located in the left circumflex (lcx) artery.A 15/3.50 flextome® cutting balloon® monorail was selected to treat the target lesion.During the procedure, the cutting balloon was advance down an unspecified guidewire.Before the device went down the coronary artery, it was noted that blood was returning back up to the shaft of the catheter.A pinhole in the balloon was noted.The balloon was never inflated and the physician decided to remove the balloon.The procedure was completed with a different device.No patient complications were reported and the patient status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The balloon protector cap was not returned for analysis.A visual and microscopic examination determined that the inner lumen had detached at the distal bond.The inner lumen was kinked at 5mm proximal to proximal end of distal markerband and at 6mm distal to distal end of the proximal markerband.A visual examination also identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Contrast media was identified within the balloon and inflation lumen.Solidified blood was present inside the guidewire lumen.The balloon was unable to be inflated due to the inner lumen detach at the distal bond.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that a balloon pinhole occurred.The target lesion was located in the left circumflex (lcx) artery.A 15/3.50 flextome cutting balloon monorail was selected to treat the target lesion.During the procedure, the cutting balloon was advance down an unspecified guidewire.Before the device went down the coronary artery, it was noted that blood was returning back up to the shaft of the catheter.A pinhole in the balloon was noted.The balloon was never inflated and the physician decided to remove the balloon.The procedure was completed with a different device.No patient complications were reported and the patient status was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4865242
• MDR Text Key: 19815597
• Report Number: 2134265-2015-03971
• Device Sequence Number: 1
• Product Code: NWX
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

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 Expiration Date: 12/19/2015
• Device Model Number: H749CBM3350150
• Device Catalogue Number: CBM335015
• Device Lot Number: 0015763593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2013
• 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: 54 YR