MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240020

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that the wire was kinked.A 330 cm rotawire was selected to treat the target lesion.During unpacking, the wire was pulled out from the hoop.It was noticed that the wire had a kink.The procedure was completed with a different device.There were no patient complication reported as the device never went inside the patient.However, device analysis revealed a fractured guide wire.

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: device was returned for analysis.A visual and tactile inspection was performed.It was observed that the device presents a body kinked at 287.8cm from the proximal end; and the distal end fractured 4.2cm approximately.The distal section with the spring tip was not returned.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).

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• 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 (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3999258
• MDR Text Key: 4954323
• Report Number: 2134265-2014-04754
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: H802228240020
• Device Catalogue Number: 22824-002
• Device Lot Number: 16742623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1