MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5081-153

Device Problems Break (1069); Material Deformation (2976); Packaging Problem (3007)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the tail end of the rebar microcatheter was already found to be broken when the device was taken out of the package. the device was replaced, and the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for a thrombectomy in acute ischemic stroke.The patient's vessel tortuosity was normal.The access vessel was the femoral artery, which was 7mm in diameter.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received clarified that the catheter was separated and kinked.The damage was noticed upon opening the package, and no prep had been performed.

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: ¿ as found condition: the rebar 18 catheter was returned for evaluation inside of a biohazard bag and a shipping box.There was no outer carton, inner pouch, dispenser coil or ifu returned with the catheter.¿ visual inspection/damage location details: the distal tip and marker band were examined; and no damages were found.The catheter body was found to be flattened at 2.5cm to 10.5cm from the distal tip.In addition, the catheter body was also found to be kinked at 6.5cm, 48.0cm, 91.0cm and 102.0cm from hub.The catheter was found intact.No separation was observed on the returned catheter.No flash or voids molded were observed in the hub.No other anomalies were observed.¿ testing/analysis: the usable length of the catheter was measured to be within specifications.The catheter was flushed with water and found to be patent.¿ conclusion: based on the analysis findings, the customer report of "catheter separation/break" was not confirmed as the returned catheter was found intact.No separation was observed on the returned catheter.However, the customer report of "catheter kink/damage" and "product damaged/deformed out of pkg" were confirmed as the returned catheter was found to be flattened and kinked at several locations.However, the cause root cause and cause for damages could not be determined.Since the outer carton, inner pouch and dispenser coil were not returned; any contribution of the outer carton, inner pouch and dispenser coil to the reported issue could not be determined.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.A formal investigation has been previously conducted regarding this issue.Based on the formal investigation, it is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.No corrective action was required; however, as a conservative approach a quality alert was then issued to improve operator awareness for all products that are currently being manufactured internally at all me dtronic sites that manufacture neurovascular product.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: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13928830
• MDR Text Key: 288694625
• Report Number: 2029214-2022-00496
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: 00847536026834
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B272957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 06/27/2022
• Supplement Dates FDA Received: 04/22/2022; 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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 Age: 62 YR
• Patient Sex: Male