MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	8888345629HP
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.When the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during catheter insertion the guide wire was being removed from the catheter and had resistance wherein an increased force had to be used to pull back the wire.When the wire was completely removed, it was found to be twisted.An x-ray revealed that the catheter was double kinked and that parts of the guide wire were visible inside the catheter.The catheter was then completely explanted, and a new catheter was implanted to resolve the issue.There was no injury to the patient from this event.It was reported 2 days later that the patient had died, however it was not related to the issue with the guide wire.The doctor stated the death was not caused by the device.He stated the cause was the sum of basic diseases of the patient, a high blood loss due to an operation performed, and the patient had been failing for weeks.
Additional Manufacturer Narrative
Evaluation summary: a device history record (dhr) review was performed to the lot and no discrepancies that may have contributed to a complaint of this nature were found.Two pictures were provided by the customer.The first picture shows the guide wire.This image shows the guide wire with signs of use and shows that the guide wire was kinked and broken.In the second picture, the guide wire is stretched inside a plastic bag.One incomplete kit was also received for analysis and investigation.The sample consisted of one guide wire which was returned with components of different products.Visual inspection was performed, and revealed that the guide wire was stretched and kinked at different points.Dimensional testing was performed identifying no issues.The reported condition was confirmed from the analysis.Based on the available information the reported condition could not be attributed to the manufacturing process.The most probable root cause can be considered as damaged during use.It must be noted that in-process controls are in place to prevent no nconforming product from leaving the manufacturing operations.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, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7072262
• Report Number: 3009211636-2017-05372
• Device Sequence Number: 1260845
• Product Code: NIE
• UDI-Device Identifier: 20884521128160
• UDI-Public: 20884521128160
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2018

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: 02/11/2022
• Device Model Number: 8888345629HP
• Device Catalogue Number: 8888345629HP
• Device Lot Number: 1706700144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 12/29/2017; 01/05/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/18/2018; 01/31/2018
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 75