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

Model Number 3822

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a tip fracture occurred.A flextome monorail cutting balloon was selected for use for a percutaneous coronary intervention procedure.Vascular access was obtained via the radial artery.The 90% stenosed, 20mmx3.0mm, concentric, de novo target lesion was located in mildly tortuous and severely calcified left anterior descending artery containing a less than 45 degree bend.The lesion was pre-dilated using a maverick balloon.Following pre-dilation, the lesion was 80% stenosed.During the procedure, the flextome cutting balloon was advanced to the lesion, however, the device was found unable to inflate.Subsequently, the device was removed slowly and smoothly with no resistance noted.The tip of the device was found to be fractured after it was removed.No fragments of the device was left inside the patient.Consequently, the procedure was completed with a different device.No complications reported and patient is stable.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8545011
• MDR Text Key: 142924616
• Report Number: 2134265-2019-04280
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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 Assistant
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0023188670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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
• Treatment: MAVERICK 2.75/20 FOR PRE-DILATION; RUNTHROUGH NS GUIDEWIRE; TERUMO IL4.0 GUIDE CATHETER
• Patient Age: 67 YR