MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05216.It was reported that speed was unstable, burr became stuck on rotawire and rotawire fracture occurred.The target lesion was located in a coronary vessel.A 1.50mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During procedure, it was noted that a large capacity of nitrogen gas was supplied and the burr rotated at high speed.Furthermore, it was noted that the burr became stuck on the rotawire and the rotawire became separated.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the rotawire and burr were never used inside patient and that the burr became stuck on the rotawire outside the patient's body.The patient's condition post-procedure was stable.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7607011
• MDR Text Key: 111312885
• Report Number: 2134265-2018-05217
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• 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,Followup
• Report Date: 05/22/2018

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: 09/07/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 21104058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• 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