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

Model Number 3822

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.An examination of the returned device identified blood inside the balloon which is an indication of a leak.The balloon wings were relaxed.Functional testing of balloon could not be performed due to condition of returned device (the device was returned in 2 pieces).However, all blades were present and fully bonded to the balloon material.No issues were noted with the tip and its markerbands that may have potentially contributed to the complaint incident.A visual and tactile examination identified a shaft break at the port bond site and multiple hypotube kinks on several locations along the hypotube shaft.The shaft break and hypotube kinks which were observed on the shaft of the device are consistent with excessive force that could have been applied to the delivery system.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on16aug2019.It was reported that the material was damaged.A 10/3.00 flextome cutting balloon was selected for use.It was observed that material was damaged.Despite attempts for additional information no further details of the event were provided.No patient complications reported and the patient was stable.However, device analysis revealed that the shaft break at the port bond site and balloon 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8976676
• MDR Text Key: 156963223
• Report Number: 2134265-2019-10826
• 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,foreig
• Type of Report: Initial
• Report Date: 09/09/2019

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: 03/22/2020
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0020437682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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