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

Model Number	105-5092-150
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The echelon-14 micro catheter was returned for analysis.Upon visual inspection, no issues were found with the echelon-14 micro catheter hub or body.The echelon-14 micro catheter distal tip appeared to be shaped.The distal tip was found to be damaged.Upon further inspection there appeared to be a puncture at the distal marker band.The echelon-14 micro catheter was flushed, water exited from the puncture and the distal tip.One in house guidewire was hydrated and inserted into the echelon; no resistance was encountered.An in-house mandrel was unable to pass through the distal tip as it exited through the punctured location.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s reported event was confirmed, but the cause of the observed damage could not be determined.The customer does not have any information regarding puncture at the distal marker.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of coil resistance in the proximal section of an echelon catheter.Prior to resistance, the coil had been pushed from the introducer sheath smoothly.The devices had been prepared/flushed as indicated in the ifu.There were no related patient symptoms.The echelon catheter was returned and observed to have puncture damage.

• Brand Name: ECHELON
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8192831
• Report Number: 2029214-2018-01088
• Device Sequence Number: 11069017
• Product Code: KRA
• UDI-Device Identifier: 00847536005983
• UDI-Public: 00847536005983
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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: 06/11/2020
• Device Model Number: 105-5092-150
• Device Lot Number: A659226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR