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

Catalog Number SPD2-US-050-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/28/2019

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 was using a spider fx in a carotid artery stenting procedure.It was reported that, after stent deployment, multiple unsuccessful attempts were made to remove the spider.It was reported that the wire detached leaving the filter behind.It is not known how the procedure was completed.

Manufacturer Narrative

Additional information: groin access was obtained, and the sheath was placed.The physician proceeded to treat the carotid occlusion.The stent was deployed followed by angioplasty and images were obtained.The device became stuck along with the wire.Due to this the device detached from the delivery wire.It was not possible to place additional catheters distal to the occlusion.Vascular surgery consulted for possible or.No further treatment was carried out or is planned.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medwatch report# (b)(4) received.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: 8687018
• MDR Text Key: 147598632
• Report Number: 2183870-2019-00328
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068342
• UDI-Public: 00821684068342
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2019

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: 02/05/2020
• Device Catalogue Number: SPD2-US-050-320
• Device Lot Number: A592238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 08/19/2019; 08/28/2019; 09/23/2019
• Supplement Dates FDA Received: 08/23/2019; 08/29/2019; 09/24/2019
• Date Device Manufactured: 02/05/2018
• 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: 72 YR