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

Model Number 8813793009

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, on (b)(6) 2017 during insertion of a new catheter the blue lumen was occluded and the guide wire could not pass.As a result, the catheter was not used.There was no patient injury.Anecdotally the customer stated this happened on another patient but they had no specific information regarding that event.

Manufacturer Narrative

Evaluation summary: a device history (dhr) 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.In addition, all dhr are reviewed for accuracy prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since no sample, picture or video were received for testing, therefore the defect is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.No trends or triggers have been found.No action is not 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.

Manufacturer Narrative

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 matheuw ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 6997542
• MDR Text Key: 91094656
• Report Number: 3009211636-2017-05340
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20884521004808
• UDI-Public: 20884521004808
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 10/05/2018

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: 12/28/2021
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1702600150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 07/16/2018; 08/08/2018
• Supplement Dates FDA Received: 08/06/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2017
• 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 Age: 68 YR