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 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).

Event Description

It was reported that difficulty removal and rotawire fracture occurred.The 99% stenosed target lesion was located in the moderately tortuous posterior descending artery.A 330cm rotawire¿ was selected for use.During the procedure, various non-bsc devices were unable to cross the lesion.The rotawire was advanced to the lesion under a non-bsc guide catheter; however, the rotawire was also unable to cross the lesion.During the attempt to cross the lesion, the rotawire became trapped in the lesion.Attempts in removing the trapped rotawire were performed, and in the process, the spring coil portion of the tip became stretched and then detached.When the non-bsc catheter was removed, the detached component of the rotawire was retrieved.No device fragments were left inside the patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device came with an unknown catheter, the wire is not stuck in the catheter.The device has its distal tip broken and a fractured section containing the spring part of the tip was returned as well.Part of the core wire is attached at the fractured section while other section remains attached at the distal section of the device.Overall length and outer diameter (od) of the distal tip could not be measured because of the condition of the device.Od of the middle and proximal section of the device were within specifications.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

It was further reported that the lesion was calcified and the rotawire reached the calcified target lesion; however, the device could not completely cross.

• 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: 7592149
• MDR Text Key: 110779475
• Report Number: 2134265-2018-05248
• 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: 05/21/2018

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: 11/02/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0021332753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• 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
• Treatment: BALLOON CATHETER: SAPPHIRE PRO; GUIDE CATHETER: 7F LAUNCHER JR4SH; GUIDEWIRE: SION; GUIDEWIRE: XTA; MICROCATHETER: CORSAIR; MICROCATHETER: FINECROSS GT; STENT: XIENCE