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

Model Number FG13150-0615-2S

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem Bradycardia (1751)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the delivery system and pipeline vantage were prepared per the instructions for use (ifu) and delivered to the target location smoothly with no issues.The stent was deployed with no issues, and the stent opened well.The proximal end required slight wagging to fully appose.The physician did not want to take the catheter fully through to capture the sleeves, and the rhv had not been locked down.When injecting the contrast for a run, the microcatheter moved forward through the center of the braid independently, and was beyond the distal end of the braid.When trying to pull the delivery wire and sleeves to recapture, it was noted to be difficult and there was resistance.The catheter and wire were successfully removed carefully.Once removed, it was noticed the phenom had accordioned, and it was difficult to pull the wire back through.It was noted the patient had bradycardia during deployment of two occasions which resolved on drawing back the cat 5 no further issues.There was no other injury to the patient as a result of the event.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the anterior communicating (acom) artery with a max diameter of 8 mm and a 3 mm neck diameter.It was noted the patient's vessel tortuosity was minimal.Ancillary devices include a fabuki 80 cm 8f, cat 5 115cm.

Manufacturer Narrative

H3: the pipeline vantage pusher and phenom-21 micro catheter were returned for analysis.No damages or irregularities were found with the phenom-21 micro catheter hub.The pipeline vantage pusher was found extending out the hub ~41.0cm.The phenom-21 micro catheter was found bent at ~121.6cm from the proximal end.The distal ~2.6cm of the micro catheter was found accordioned.The distal tip and marker band was found slightly damaged.The pipeline vantage pusher tip coil was found extending out of the catheter tip.The tip coil was found intact.The pusher was advanced out with no resistance encountered.The distal and proximal dps restraints were found to be intact.The dps sleeves were found damaged.The hypotube was intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the spacers, advanced re-sheathing mechanism or spacers.The braid was not returned for analysis as it was implanted in the patient.The pusher was retracted back within the catheter and became stuck at the dps sleeves.Based on the analysis findings, the customer report of ¿delivery system stuck during retraction¿ and ¿catheter resistance¿ was confirmed.It is likely the damaged catheter tip and dps sleeves caused the resistance.It is possible that the damage occurred due to the reported catheter tip migration during the procedure.Other possible causes of resistance are patient vessel tortuosity, high force delivery/retrieval, pushwire damage, catheter damage, or user does not maintain continuous flush.Customer reported patient vessel was minimal and devices were prepared per ifu.The customer report of ¿catheter accordion¿ of confirmed.It is likely the accordioning occurred due to attempt to retracting the pusher through the catheter against the reported resistance.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.

• Brand Name: CATHERA
• 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: 12393912
• MDR Text Key: 271240213
• Report Number: 2029214-2021-01097
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041813
• UDI-Public: 00847536041813
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: FG13150-0615-2S
• Device Catalogue Number: FG13150-0615-2S
• Device Lot Number: AP21-035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• 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 Outcome(s): Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male