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

Catalog Number SPD2-US-070-320

Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problems Perforation of Vessels (2135); Patient Problem/Medical Problem (2688)

Event Date 02/08/2019

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 intended to use a 5mm spider fx during treatment of a calcified lesion in the proximal left superficial femoral artery (sfa).Little tortuosity was reported in the 6mm artery.A non medtronic 6fr sheath was used.The vessel was not predilated.The ifu was followed.It was reported that during withdrawal of the spider, resistance was encountered.The spider got stuck and would not come out and the sheath was backing out.The spider and sheath, with the spider still inside, were removed together.It was reported that the catheter was gripped at the distal end and a kink was observed at the retrieval end of the device.Bleeding occurred and could not be controlled so a cutdown was performed and the vessel was stitched closed to repair the vessel.

Manufacturer Narrative

Device evaluation the spider fx was inspected and found the capture wire/filter assembly was loaded the blue retrieval catheter.The ro horseshoe was within the distal tip of the catheter.It was observed buckling of the retrieval catheter at 12cm and 21 cm.The proximal port of the retrieval catheter showed the catheter bend up at an approximate 90 degree angle.The green delivery catheter was inspected and found no damages.Functional testing: the capture wire was pushed forward and the filter advanced with no resistance.The capture wire retracted and encountered resistance, approximately 0.2cm of the filter remained outside the catheter.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: 8357238
• MDR Text Key: 136725078
• Report Number: 2183870-2019-00081
• Device Sequence Number: 1
• Product Code: NTE
• 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
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPD2-US-070-320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR