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

Model Number SPD2-US-060-320

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation loosely, within a sealed plastic biohazard bag.The device was returned within the plastic hoop.No ancillary devices or images were received with the device.The spiderfx device was removed from the returned packaging for evaluation.A dried blood-like substance was noted on the returned components.The filter assembly was loaded in the delivery catheter, which was approximately 7.0cm proximal to the distal end of the green delivery catheter.It was noted that there was a bend at the location as well, approximately 8.0cm proximal from the tip.Multiple kinks were observed along the distal segment of the green delivery catheter.Bends were noted, in the proximal segment of the green delivery catheter, approximately 31.7cm and 38.5cm proximal from the delivery catheter¿s distal tip.Multiple kinks were also observed in the clear pebax section of the catheter between approximately 27.3cm and 28.1cm proximal to the delivery catheter distal tip.A bend was also noted in the white shaft of the catheter approximately 54.0cm proximal to the delivery catheter¿s distal tip.A bend was noted in the capture wire at the same location.Multiple kinks were noted on the blue retrieval catheter approximately 11.25cm, 12.6cm, 17.9cm, 20.1cm proximal from the delivery catheter distal tip.The device was able to advanced through the distal tip of the green delivery catheter.The filter basket was compressed and the braids of the filter were adhered together, likely by coagulated biologics and/or contrast.The distal tip was submerged in water and the filter basket was able to expand.The filter assembly was inspected and observed the coiled tip was missing from the capture wire.It was noted that the capture wire was bent distal to the location of the coiled tip.Proximal to the filter basket, a kink was noted in the capture wire approximately 4.8cm proximal to the capture wire tip.The coiled tip was not returned for evaluation.The total length of the returned connector to coil length was approximately 3.0cm.Microscopic inspection revealed the fracture face is blunt.Biological debris noted on the filter basket.No anomalies were noted.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a spider fx embolic protection device during procedure.The device was prepped per ifu with no issues identified.It was reported that the wire tip defect occurred during procedure.An new medtronic device was used to complete the procedure.There was no patient injury reported.

• 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 ; IE ; 091708734
• MDR Report Key: 10262791
• MDR Text Key: 200045380
• Report Number: 2183870-2020-00216
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068366
• UDI-Public: 00821684068366
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: SPD2-US-060-320
• Device Catalogue Number: SPD2-US-060-320
• Device Lot Number: A904102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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