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

Model Number H802228240022

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device was returned for analysis.Visual inspection observed the body and distal tip of the rotawire were kinked.Also, the spring tip solder joint was missing on the proximal side at the attachment between the wire and the spring tip.Dimensional inspection of the rotawire were within specifications.The device was sent for material analysis which revealed an indication that a solder residue was noted on the rotawire's surface.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-08964.Reportable based on device analysis completed on (b)(6) 2017.It was reported that the rotawire became kinked.The 90% stenosed target lesions were located in the moderately tortuous and severely calcified mid right coronary artery and the atrioventricular branch.A 330cm rotawire was selected to advance.During introduction, a kink was noted on the rotawire causing difficulty in advancing the rotaburr.The rotawire was removed from the patient's body and completed the procedure with another of the same rotawire.No patient complications were reported.However, device analysis revealed a missing spring tip solder joint.

• 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: 6833301
• MDR Text Key: 84118023
• Report Number: 2134265-2017-08336
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)20180816(10)19604242
• 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
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 19604242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2016
• 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