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

Model Number	SPD2-US-040-320
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the spiderfx device was received within a sealed biohazard pouch, and loosely coiled within its opened labeled pouch along with its transportation hoop.It was noted while still within the sealed biohazard pouch that the distal tip assembly of the spiderfx had detached from the spiderfx capture wire.The spiderfx distal assembly, exhibited a kink fracture face from the capture wire, a sharp kink at the filter basket¿s proximal radiopaque marker band, no damage was noted at the proximal radiopaque marker band, a kink in the flex connector, no damage was noted at the distal radiopaque marker band, and a bent/curved floppy distal tip.All components of the spiderfx distal assembly were accounted for.The fracture face on the capture wire exhibited a kinked fracture.The capture wire also exhibited a kink distal of the snap-ring.The duel ended catheter exhibited kinking of the delivery catheter in the area of its transparent section.Technical analysis of the returned device revealed kinking damage to the delivery catheter, capture wire, and separation of the distal assembly.The separated distal assembly exhibited kinking in several areas.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A spider fx complaint was received and it was reported there was not a product issue but the physician had selected the incorrect size for treatment.The device was received for analysis and it was confirmed the device was used in the patient due to the presence of biological debris.The distal assembly was visualized as being loose within the pouch.The spider fx capture wire had snapped just proximal of the spider fx filter.The device was replaced to complete the procedure.It is unknown when the detachment occurred.No patient injury reported.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Common Device Name: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9937262
• Report Number: 2183870-2020-00103
• Device Sequence Number: 10923562
• Product Code: NTE
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111010
• 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): 04/10/2020

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: 03/12/2021
• Device Model Number: SPD2-US-040-320
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A798036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1