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

Catalog Number SPD2-US-060-320

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used a hawkone h1-m device with a non-medtronic 6fr sheath and 0.014 spider fx embolic protection device during treatment of a 300mm plaque cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa) of diameter 5-6mm.Severe tortuosity and severe calcification were reported.The target lesion was described as fibrous, calcified plaque.The ifu was followed and the device was prepped without issue.The lesion was pre-dilated with a 3x150 nanocross pta balloon.A kink was observed on the spider fx during initial advancement to the lesion.When the hawkone was being removed for cleaning it would not re-enter the 6f sheath.The body of the hawkone came out but the nosecone was reported to have broken off and remained in the body along with the spider.A 7fr sheath was exchanged but they were unable to retrieve the devices.The spider and hawk were pulled back from the right common femoral to the left common femoral.The right sfa was treated with a 5x300 pacific xtreme pta balloon.The patient was taken to surgery to have both devices removed.The surgery was reported to have been successful.

Manufacturer Narrative

The right sfa was treated with a 5x300 pacific xtreme pta balloon successfully.All the device components were removed from the patient.The physician has had a follow-up appointment with the patient.The patient is reported to be doing fine.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 8631204
• MDR Text Key: 145742743
• Report Number: 2183870-2019-00290
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068366
• UDI-Public: 00821684068366
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2021
• Device Catalogue Number: SPD2-US-060-320
• Device Lot Number: A804482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/29/2019; 08/01/2019
• Supplement Dates FDA Received: 06/26/2019; 08/06/2019
• Date Device Manufactured: 03/25/2019
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 87