MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8831661001

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during catheter insertion/puncturing of the femoral vein, while on the insertion of the guide wire, it was impossible to withdraw the guide wire through the catheter; blocking on the y-hub (separation of vein and arterial lumen).Withdrawing the guide wire would increase the risk of bleeding.In order to resolve the issue, a new catheter was used without issue.Insertion site was treated prior to placement, catheter was not repaired, and there was no leak.As a result, there was delay in the dialysis treatment and the patient had to stay in hospital longer.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during catheter insertion/puncturing of the femoral vein, on insertion of the guide wire in the patient, it was impossible to withdraw the guide wire through the catheter; there was blocking on the y-hub (separation of vein and arteriallumen), it was stated that the catheter lumen was blocked.Withdrawing the guide wire would increase the risk of bleeding and was stated that the guide wire provided with the kit was used.In order to resolve the issue, a new catheter was used without issue and re puncture was done.Insertion site was treated prior to placement, catheter was not repaired, and there was no leak.There was a minimal blood loss and no intervention was needed.As a result, there was delay in the dialysis treatment.

• Brand Name: MAHURKAR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8381722
• MDR Text Key: 137557681
• Report Number: 3009211636-2019-00053
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521005235
• UDI-Public: 10884521005235
• Combination Product (y/n): N
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: 8831661001
• Device Catalogue Number: 8831661001
• Device Lot Number: 1731200118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 78