MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Model Number	8888572545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reports the doctor had placed the chest tube during open heart and was being removed on (b)(6) 2017 when it broke off into the patient.The customer further reports they had to do surgery to remove the broken catheter.
Additional Manufacturer Narrative
A query of non conformance reports (ncr)¿s was reviewed and confirmed that there is no ncr for this lot number.Since this complaint has been pending additional information from the customer for a period of more than 60 days and as the sample is not available for evaluation nor were photographs provided the issue could not be confirmed.The root cause and corrective actions could not be identified since the sample was not received for evaluation.This complaint will be closed with no further action; if sample is available later on, the complaint will be reopen for updated if it¿s required.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: ARGYLE
• Common Device Name: CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana,mx
• MDR Report Key: 6550785
• Report Number: 9612030-2017-05068
• Device Sequence Number: 13705736
• Product Code: GBS
• UDI-Device Identifier: 20884521025452
• UDI-Public: 20884521025452
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: 09/30/2021
• Device Model Number: 8888572545
• Device Catalogue Number: 8888572545
• Device Lot Number: 162950135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 05/06/2017
• Supplement Report FDA Received Date: 12/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other