MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

Catalog Number SPD2-US-030-320

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2017

Event Type  Injury  

Event Description

The physician was using a spider fx embolic protection device while treating a moderately tortuous and moderately calcified mid left coronary artery lesion exhibiting chronic total occlusion.The vessel was not pre-dilated.A non-mdt guidewire was used.The ifu was followed during the procedure.It was reported that once the filter was positioned, the physician was unable to open the blockage.It was reported that when the physician attempted to recapture the filter, the tip detached.The detached tip was left in the patient.The physician commented that the tip would lodge in the branch.The surgery was turned down.No other patient injury was reported.

Manufacturer Narrative

Additional information received: it was reported that the patient expired one week post procedure on (b)(6) 2017.V-fib after mi was the reported cause of death.It was reported that the death was not device related.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7127744
• MDR Text Key: 95165754
• Report Number: 2183870-2017-00594
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068304
• UDI-Public: 00821684068304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2018
• Device Catalogue Number: SPD2-US-030-320
• Device Lot Number: A274815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Date Device Manufactured: 05/10/2016
• 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 Outcome(s): Other
• Patient Weight: 102