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

Model Number 8813793009

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

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 procedure, the kit guide wire could not pass through the catheter lumen.It was stated there was indication of blockage near the hub of catheter.It was reported there was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: that the guide wire was received coiled and twisted.The distal end of the guide wire was bent.The catheter was received.The 10fr and 12fr tissue dilator¿s were received.A functional evaluation found that the guide wire was inserted but didn't insert far because of the bend.The catheter was submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.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.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 7847504
• MDR Text Key: 119346218
• Report Number: 3009211636-2018-00299
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20884521004808
• UDI-Public: 20884521004808
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943349
• 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
• Report Date: 11/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1632600174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2016
• 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 Age: 49 YR