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 02/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use a spider to treat a fibrous lesion with little calcification and 90% stenosis in the proximal / mid / distal superficial femoral artery (sfa) and popliteal artery.Moderate tortuosity was reported.A non medtronic 7fr sheath was used.The vessel was not predilated.The ifu was followed.It was reported that the distal end of the filter broke off while trying to recapture with a 0.35 trailblazer.The detached portion of the filter was snared and the case was completed without incident.No patient injury was reported.

Manufacturer Narrative

Device evaluation the spider fx was removed from the packaging and inspected.The capture wire was fractured into two segments.The distal portion included the filter assembly.The filter braids were curved at and approximate 90 degree angle.The filter assembly showed the proximal end of the capture was outside of the proximal marker band and curved distally.At the area of the fracture, the capture wire was looped approximately 360 degrees.The flex connector remained intact.Bending to the coiled tip was noted.The proximal segment of the capture wire was analyzed and noted at the distal end the wire was curved back approximately 180 degrees.The approximate length of the capture wire distal the snap location was 183cm.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: no resistance was encountered when advancing the delivery system.It was reported that the distal end of the filter broke in the landing zone distal to the lesion.The detached portion was recaptured with a 0.35 trailblazer.There was no compromise to the catheter during retrieval.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: 8357150
• MDR Text Key: 136725585
• Report Number: 2183870-2019-00079
• 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: 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: 05/21/2019

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: 05/01/2020
• Device Catalogue Number: SPD2-US-050-320
• Device Lot Number: A639034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/02/2019; 05/17/2019
• Supplement Dates FDA Received: 03/19/2019; 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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: 65 YR
• Patient Weight: 66