MAUDE Adverse Event Report: COVIDIEN (IRVINE) MICROMEWI; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 41063-01

Device Problem Break (1069)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for analysis but has yet not been received.

Event Description

Medtronic received report that the infusion catheter broke when it was removed, after the urokinase thrombolysis medication was delivered.The medication was infused for approximately half an hour or so.The treating vessel was reported to have occluded as a result of the broken catheter.The patient was scheduled for surgery to removed the separated catheter.26cm of the catheter were removed.The treating vessel was posterior tibial artery.The vessel was severely calcified and moderate in tortuosity.The artery diameter was 3mm and 5mm in length.The patient was reported to be doing well.

Manufacturer Narrative

The catheter was returned for analysis separated into two segments.It appears all segments of the catheter were returned.The catheter appears to have separated at a fuse joint.The tubing material of the separated ends of the catheter segments exhibited stretching, necking and jagged edges.No other anomalies were observed.The investigation is still underway.When the investigation is complete a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Based on the device analysis and reported information, the report of catheter separation was confirmed, as the catheter was returned separated into two segments.The broken ends of the returned catheter segments exhibited with plastic deformation (stretching, necking and jagged edges).Which indicates that the infusion catheter separated, as the tensile strength of the tubing material was exceeded.However, it is unknown what caused the tensile failure.It is possible the patient¿s severely calcified and moderate vessel tortuosity may have contributed to the reported event.No damages were found with the returned catheter that would have interfered with the introducer sheath during retrieval (i.E.Bump or protrusion).The lot history record showed no discrepancies that would have contributed to the reported experience.All products are 100% inspected for damages and irregularities during manufacture.Per the peripheral blood clot therapy products instructions for use (ifu): warnings ¿ ¿never advance or withdraw an intraluminal device against resistance until the cause of the resistance is determined by fluoroscopy.Excessive force against resistance may result in damage to the device or vessel perforation.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: MICROMEWI
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6955942
• MDR Text Key: 89583006
• Report Number: 2029214-2017-01154
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K940634
• 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,Followup,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: 41063-01
• Device Lot Number: A443002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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): Required Intervention