MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) FILTERWIRE EZ¿; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number H749391421900

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The device returned is stuck inside of a fg sterling mr device, however, the filterwire has the spring tip damaged (curvy).The outer diameter dimensions were found within specification.Sheathing and unsheathing test was not performed due to the stuck condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-13203.Reportable based on device analysis completed on 13-dec-2017.It was reported that the tip of the device was kinked.The target lesion was located in the moderately tortuous coronary artery.A 190cm filterwire ez¿ was selected for use.During preparation, upon unpacking, the wire tip got kinked while removing the yellow sheath.The procedure was completed with another of the same device.No patient complications reported.However, device analysis revealed that the filterwire was stuck inside an fg sterling mr device.

• Brand Name: FILTERWIRE EZ¿
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7159446
• MDR Text Key: 96216824
• Report Number: 2134265-2017-13052
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K063313
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2019
• Device Model Number: H749391421900
• Device Catalogue Number: 39142-190
• Device Lot Number: 20340197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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