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

Catalog Number SPD2-060-190

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Damaged by Another Device (2915); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the spider fx was returned inside a clear pouch with a portion of the carton box which indicated the lot information.The lot number indicated was a964746.A 0.014" guidewire was returned.The spider fx was returned with the delivery catheter fractured apart with the capture wire loaded in both segments of the delivery catheter.The distal tip of the delivery catheter showed a 0.014" guidewire exposed outside of the tip of the catheter.The exposed guidewire was bent an curved.No damage was noted to the distal tip of the delivery catheter.The fracture of the delivery catheter occurred at the primary wire port.At the location of the fracture, the filter was exposed protruding out from the distal fracture face.It was observed the guidewire was loaded delivery catheter through the same catheter lumen.The exposed guidewire from the fracture face of the catheter showed looping/bending to the capture wire.The proximal segment of the delivery catheter showed the capture remained loaded.The fracture face was ductile in nature consistent with exposure to excessive tensile forces.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a 6mm spider fx embolic protection device during procedure.Ifu was not followed.The reason was suspected that the capture wire was inserted without removing the 0.014" wire.During procedure, resistance was felt while advancing device with severe resistance felt.The delivery catheter was not able to cross and the component broke.The entire system was removed and replaced with a new product, the procedure was performed without any issues, and was completed successfully.It was reported that it was planned to insert and deploy the capture wire after making the delivery end to pass through the lesion, however, the capture wire was inserted without removing the non-medtronic 0.014" wire during delivery.Resistance was strong and it got stuck.The insertion of the capture wire was given up and capture wire was attempted to be pulled out, but there was also resistance, and it did not move.The entire catheter system was removed, the device was replaced with a new one, and the procedure was completed successfully.There was no patient injury reported.

Event Description

(b)(4).

Manufacturer Narrative

Additional information: the capture wire was hydrated prior to insertion attempt.The filter portion of the spider detached within the patient and was removed.The entire catheter system, delivery system, and capture was safely removed from the patient.There was no vessel damage noted.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
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10552162
• MDR Text Key: 207539053
• Report Number: 2183870-2020-00299
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: SPD2-060-190
• Device Lot Number: A964746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1