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 Patient Involvement (2645)

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.A visual inspection found that the wire is broken near the distal end 329.3cm from the proximal end.The distal tip was returned.The spring tip is unraveled and the body is kinked in the middle of the device.Overall length and outer diameter of the distal tip could not be measured due to the device condition.All other outer diameter measurements are within specification.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

Reportable based on device analysis completed on 27jun2016.It was reported that the rotawire tip was kinked.A 330cm rotawire was being removed from the protective hoop during preparation when it was noted the tip of the wire was kinked.The device was not used in the procedure.No patient complications were reported.However, device analysis revealed that the wire was broken.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5813435
• MDR Text Key: 50185373
• Report Number: 2134265-2016-06333
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 18892813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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
• Patient Age: 74 YR