MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VENT CATHETER; VENT CATHETER WITH MALLEABLE BODY

Model Number LVF 18 H

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 01/16/2014

Event Type  Injury  

Event Description

It was reported that the connection cone on the vent catheter detached during a procedure which potentially led to postoperative neurological deficit and/or dysfunction.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device (b)(4).(b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted if add'l info becomes available.

• Brand Name: VENT CATHETER
• Type of Device: VENT CATHETER WITH MALLEABLE BODY
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3647918
• MDR Text Key: 4182645
• Report Number: 8010762-2014-00032
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2014,01/17/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: LVF 18 H
• Device Catalogue Number: 701005076
• Device Lot Number: 92116989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: 80 YR