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

Model Number	8817146001
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, when implanting the catheter for plasmapheresis, the guide wire presented a defect.It was stated that the guide wire was stretched and it did not leave the catheter.It was necessary for its withdrawal and for a new passage.The physician had to perform the catheter replacement and insert it again so that the patient could have hemodialysis session.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, when implanting the catheter for plasmapheresis, the guide wire was loose.The physician stated that in the removal of the guide wire, it was stretched and it did not leave the catheter.It was necessary to remove the guide wire together with the catheter entirely and a new puncture was done.The physician had to perform the catheter replacement using a new needle and guide wire from another kit so that the patient could have hemodialysis session.A post procedure x-ray was done to the patient.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph.The physical sample involved in the reported incident was not returned for evaluation.One picture was provided by the customer.Visual evaluation of this photo was performed, the image shows one polybag.However, it is not possible to determine a defective condition with the evidence provided.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAHURKAR
• Common Device Name: 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: 7714509
• Report Number: 3009211636-2018-00245
• Device Sequence Number: 1619148
• Product Code: FOZ
• UDI-Device Identifier: 20884521005027
• UDI-Public: 20884521005027
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K943349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: 8817146001
• Device Catalogue Number: 8817146001
• Device Lot Number: 1709700109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/03/2018; 08/08/2018; 09/17/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/20/2018; 10/02/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR