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

Model Number SPD2-US-070-320

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2022

Event Type  Injury  

Event Description

A spider fx was used during the treatment of a 10mm plaque lesion in the mid superficial femoral artery.The degree of calcification was mild and there was no tortuosity.The artery diameter was 6mm.The vessel was not predilated.A 6 fr sheath was used.The ifu was followed  during preparation, procedure and post-procedure.It was reported after the da was used, the physician was attempting to remove the filter from the patients body.  the filter could not be captured by the catheter.The physician attempted to remove through sheath but the filter would not fully capture into the sheath.Manual aspiration was attempted to remove some debris in filter, then removal was re attempted.Filter basket then broke off.Physician used a snare to grab basket and attempted to remove basket and sheath from body.Sheath came out but basket stuck in hole in artery. patient was taken to or for basket removal.

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.

Manufacturer Narrative

Product analysis visual inspection: only the filter basket of the device was returned in a biohazard bag in a shelf carton filter basket was detached tissue debris was observed in the filter basket.Damage to the mesh wires was observed slight damage was observed to the distal floppy tip 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: TEMPORARY CAROTID CATHETER FOR EMBOLIC 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16221618
• MDR Text Key: 307879898
• Report Number: 2183870-2023-00026
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068380
• UDI-Public: 00821684068380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPD2-US-070-320
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: B480702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/22/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male