MAUDE Adverse Event Report: COVIDIEN SPIDER FX

Catalog Number	SPD2-US-030-190
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the spiderfx device was received with the filter being partially exposed.Visual inspection under magnification reveal lateral compression of green dual ended delivery catheter.The distal tip coil wire was observed to be fractured.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was intending to use a spiderfx for treatment.It was reported that the physician prolapsed the device and bent the wire tip distal to the spider basket.The procedure was completed successfully.No adverse event reported for the patient.When the device was returned to the manufacturing facility, it was noted that the device was damaged.

• Brand Name: SPIDER FX
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8801635
• Report Number: 2183870-2019-00374
• Device Sequence Number: 320089
• Product Code: NTE
• UDI-Device Identifier: 00821684068298
• UDI-Public: 00821684068298
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 07/18/2020
• Device Catalogue Number: SPD2-US-030-190
• Device Lot Number: A678613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1