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

Model Number	8830415003
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while performing insertion procedure, the device¿s guide wire was not negotiating/passing through the lumen of the catheter.The doctor confirmed for blockage occlusion inside the lumen.It was also reported that the procedure was completed by replacing the device with a new one.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary a device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.All dhr are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Two photos were provided by the customer.Visual evaluations of these photos were performed.The first picture showed a catheter above an original labeling.Also, in this picture, it showed that the catheter was manipulated, however, the photos does not give enough information to confirm the defect.As per the instructions for use (ifu), the correct way to insert the catheter into a patient is by inserting the guide wire first.This will help to place the catheter in the right position inside of the patient.This defect has not been confirmed.The product sample was not returned to the manufacturing site for review.Based on the available information, it can be concluded that product was manufactured according to specifications, therefore the most probable cause can be considered as misuse; this defect was more likely patient related condition / catheter placement by the user.No triggers or trends were identified.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.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: 7341790
• Report Number: 3009211636-2018-00074
• Device Sequence Number: 11177034
• Product Code: FOZ
• UDI-Device Identifier: 10884521005174
• UDI-Public: 10884521005174
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K943349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 8830415003
• Device Catalogue Number: 8830415003
• Device Lot Number: 331102X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 55