MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX072-105-08MP
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that 035 wire had resistance encountered in the middle.It was reported there was catheter resistance that occurred in the middle of the catheter.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.Ancillary devices include a 6f shuttle sheath, 6f navien guide catheter, phenom 17 45 microcatheter, and synchro 14 guidewire.Additional information received reported that the navien was delivered with 035 wire.No patient symptoms were reported.
Additional Manufacturer Narrative
Product analysis #705506256: equipment used: vis (m-81805), 203cm ruler (m-83360), 0.067in mandrel as found condition: the navien catheter was returned for analysis within a shipping box and within a plastic bio-pouch.Damage location details: no damages were found with the navien catheter hub.No bends or kinks were found with the navien catheter body.The navien catheter distal tip was found in good condition.Testing/analysis: the navien catheter was flushed, water exited from the distal tip.An in-house mandrel was inserted into the navien catheter, resistance was encountered at ~12.0cm from the proximal end of the catheter hub.The navien catheter was dissected (cut) and the catheter inner liner was found damaged from ~12.0cm to ~19.0cm from the proximal end of the catheter hub.Conclusion: based on the device analysis and reported information, the customer¿s ¿catheter resistance¿ report was confirmed.In this event, it is likely the damages found with the navien catheter inner liner contributed to the reported resistance with the guidewire.However, the cause for the catheter liner damage could not be determined.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.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: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 16832592
• Report Number: 2029214-2023-00715
• Device Sequence Number: 7132346
• Product Code: DQY
• UDI-Device Identifier: 00847536017887
• UDI-Public: 00847536017887
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K110055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 12/01/2024
• Device Model Number: RFX072-105-08MP
• Device Catalogue Number: RFX072-105-08MP
• Device Lot Number: B486065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown