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

Model Number H749391421900

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-07583.It was reported that the device could not be seen under fluoroscopy.The 80% stenosed target lesion was located at the severely tortuous internal carotid - common carotid artery.Two filterwire ez¿ were selected for use.During the procedure, resistance was encountered during the insertion of the first filterwire.The device was removed since it could not be seen under fluoroscopy and the tip of the filterwire became strained bend.The second filterwire was then inserted but still resistance was encountered and was not seen under fluoroscopy with a trained bend.The device was removed and replaced with another of the same device.No patient complications were reported.

• 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: 6766652
• MDR Text Key: 81846754
• Report Number: 2134265-2017-07584
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Model Number: H749391421900
• Device Catalogue Number: 39142-190
• Device Lot Number: 20509713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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
• Treatment: GUIDING CATHETER - 8F FLOWGATE2 95CM
• Patient Age: 72 YR