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

Model Number 3820

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination of the device identified a kink in the mid shaft extrusion.The kink was located at 3.3cm proximal to the port.An examination of the balloon found traces of solidified blood was present.Attempts to inflate the balloon failed.The balloon was placed in a beaker of water and a massage of the balloon identified air bubbles consistent with a leak.Microscopic examination identified a pinhole leak in the balloon material just distal to the proximal markerband.No damage was observed to the tip.An examination of the markerbands identified no issues.

Event Description

Reportable based on device analysis completed on 18dec2020.It was reported that the balloon could not cross the lesion.The 85% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 06/2.75 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon could not cross the lesion.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there was a pinhole leak.

• 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: 11066230
• MDR Text Key: 223442483
• Report Number: 2134265-2020-18410
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0024637645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 72