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

Model Number	RFX072-105-08MP
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The navien catheter (model: rfx072-105-08mp lot: a981154) was returned for analysis.The navien useable length was measured to be ~106.9cm which is within specification (specification: 105cm ± 3cm).Upon visual examination, no damages or irregularities were found with the navien hub.The navien catheter body inner coil was found to be broken at ~15.0cm from the proximal end with the outer jacket and inner liner found to be unbroken.The distal tip and marker band were found to be slightly crushed.The catheter was flushed, and water exited the catheter with no issues and no leak at the broken location.No other anomalies were observed.Based on the device analysis, reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.The customer report of ¿prod damaged/deformed out of pkg¿ could not be confirmed but cannot be ruled out.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.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.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Therefore, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that after opening the package, it was found that the catheter was kinked in the middle section.The operation proceeded smoothly after using a replacement product of the same kind.It was indicated that all devices were prepared and flushed as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Additional information received reported that there was no damage or evidence of tampering to the device packaging.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10973177
• Report Number: 2029214-2020-01260
• Device Sequence Number: 14517643
• Product Code: DQY
• UDI-Device Identifier: 00847536017887
• UDI-Public: 00847536017887
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 02/22/2022
• Device Model Number: RFX072-105-08MP
• Device Catalogue Number: RFX072-105-08MP
• Device Lot Number: A981154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR