MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7585

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the inflation lumen and guidewire lumen.The balloon was loosely folded.There were numerous hypotube kinks throughout the device.There was a complete hypotube separation 20.5cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported shaft kink, as there were numerous kinks in the hypotube with a complete hypotube separation resulting from a kink.

Event Description

Reportable based on device analysis completed on 14-oct-2019.It was reported that shaft kink was encountered.A 2.00mm x 15mm maverick 2 balloon catheter was selected for use.However, during procedure, it was noted that the delivery shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• Brand Name: MAVERICK
• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9281842
• MDR Text Key: 168296790
• Report Number: 2134265-2019-13427
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: 08714729370062
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860019
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0022644637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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: 65 YR
• Patient Weight: 63