MAUDE Adverse Event Report: COVIDIEN SPIDER FX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

Catalog Number	SPD2-US-040-320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was using a spider fx filter along with a turbohawk directional atherectomy device for treatment of a minimally tortuous, slightly calcified lesion.No resistance was felt during advancement of the device.It was reported that the spider was broken in the patient during the procedure.A physician retrieved it and replaced it with another medtronic product.The procedure was completed.No intervention was required.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary the spiderfx was received within a large sealed plastic biohazard pouch and within sealed sterilization pouches.One pouch contained the loose distal tip assembly of the spiderfx.The tapered distal capture wire exhibited a bend that terminated in a kink separation face.This type of damage is associated with the capture wire prolapsing into the deployed filter basket causing the wire to bend and kink.The tapered distal capture wire was separated distal of the filter basket proximal radiopaque marker band.The floppy distal tip was examined.The coil is intact but does exhibit bending and coil offset separation.All distal assembly components are accounted for.The duel ended catheter was received loose within the other sealed sterilization pouch.No abnormality or deformity was noted in its examination.The protective transportation hoop was received with the spiderfx 320cm capture loaded within it.The distal end of the capture wire exhibits a kink and a kink separation face.The capture wire was removed from the hoop for further examination and measurement.Approximately 252cm from the proximal end of the capture wire is a kink that is paired with a second kink approximately 253.2cm proximal end of the capture wire to form a ¿z¿ kink.The third kink located in the capture wire is approximately 313.8cm from the proximal end of the capture wire.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Common Device Name: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6720398
• Report Number: 2183870-2017-00307
• Device Sequence Number: 16392083
• Product Code: NFA
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K063785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2018
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A317063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1