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 03/06/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2015.It was reported that a guide wire kink occurred.The target lesion was located in the coronary artery.A 330cm rotawire was used to treat the lesion.Upon unpacking, it was observed that the wire was kinked.The procedure was completed with another of the same device.There were no complications reported and the patient's status was stable.However, device analysis revealed a broken wire.

Manufacturer Narrative

Age at the time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for evaluation.A visual inspection was performed and it was observed that the wire is broken in two sections, at 20.7cm and at 185.5cm approx.From the distal end; also, the proximal section of the wire was not returned.Moreover, evidence of tension/torsion overload was noted to the fracture of the distal section.Additionally, the wire has a kinked at the middle section of the wire.All the outer diameter measurements are within the specifications.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: 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: 4772720
• MDR Text Key: 15238550
• Report Number: 2134265-2015-03054
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2016
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0016676125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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