MAUDE Adverse Event Report: COVIDIEN (IRVINE) MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

The microcatheter will not be returned for analysis as it remains within the patient.Based on the reported information, the report of catheter entrapment could not be confirmed and the cause could not be determined.It is possible the slightly severe tortuosity and small diameter vessel contributed to the reported issues.Per the catheter¿s, instructions for use: if catheter entrapment is suspected (with any embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage.Slowly remove any ¿slack¿ in the distal catheter shaft.Gently and slowly apply 3-5 cm traction to the catheter to begin catheter retrieval.Should catheter removal become difficult, the following will assist in catheter retrieval.Assess the following parameters by observing the distal shaft of the catheter: vessel straightening; traction on embolic cast; catheter tip releasing from embolic cast.Further traction (of 3-5 cm) may be applied gently if necessary to transfer distal catheter shaft.Hold this traction for a few seconds and release.Assess traction of vasculature to minimize risk of hemorrhage.This process can be repeated intermittently until catheter is retrieved.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.

Event Description

Medtronic received report that during the procedure for 2 mm of cerebral aneurysm located at va-pica, the microcatheter could reach the target aneurysm.Instead of coiling, competitor embolic material was used to embolize the aneurysm.After injecting liquid embolic material, the microcatheter was attempted to be retrieved, but was unable to be remove from the patient.The device was forcibly pulled but still could not be retrieved.Therefore, the catheter hub was cut off to attempt removal with snare device.These attempts were in vain.A stent device was place in the external iliac artery to hold the proximal section of microcatheter.Open surgery was planned for later time.The anatomy was slightly severe, and small in diameter.The patient was reported to have been asymptomatic post intervention.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: medtronic miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6611654
• MDR Text Key: 76664307
• Report Number: 2029214-2017-00727
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Disability