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

Model Number 3822

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Event date: the event date was populated as the first day ((b)(6) 2019) of the bsc aware date as it was not provided in the record.

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in moderately tortuous and moderately calcified artery.A 10/4.00 flextome cutting balloon was selected for use.During procedure, the cutting balloon was delivered into the lesion area.It was attempted to inflate twice, however a pinhole was noted.However, it was further reported that the device was completely removed from the patient's body.The procedure was completed with another of the same balloon.No patient complications reported.Patient wa fine post procedure.

Manufacturer Narrative

B3: event date: the event date was populated as the first day on (b)(6) 2019) of the bsc aware date as it was not provided in the record.

Event Description

It was reported that a balloon failed to inflate.A 10x3.5 flextome cutting balloon was selected to treat a moderately tortuous and stenosed lesion.The flextome was delivered to the lesion.The balloon did not inflate due to a pinhole in the balloon preventing inflation.The flextome was removed and replaced with a 10x40 flextome cutting balloon.The balloon again failed to inflate.The flextome was removed and replaced with another cutting balloon.The procedure was completed with no patient complications and the patient's condition was fine.

• 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
• MDR Report Key: 9136215
• MDR Text Key: 160729755
• Report Number: 2134265-2019-11788
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0023955272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1