MAUDE Adverse Event Report: HALYARD ON-Q CATHETER; CATHETERS

Device Problems Stretched (1601); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2014

Event Type  malfunction  

Event Description

Procedure: heart valve replacement and repair to aortic aneurysm ((b)(6) 2014).Cathplace: lateral to mid line chest incision (left chest).It was reported that a pt's catheter broke upon removal by the surgeon.On (b)(6) 2014, the day the pt was discharged from the hospital.The pt reported that the left catheter became stuck.Then the surgeon attempted to remove it; the catheter stretched and broke.The pt was given the option of leaving the segment of the catheter in or to have a procedure to remove the segment.The pt left the hospital without removal of the catheter segment on (b)(6) 2014.At the time of this report the pt is in discussion with her care providers in regards to the risks and benefits of leaving the broken catheter segment in or removing it.The pt reported that she is symptomatic with pain where the catheter segment was left in the left chest (next to the pt's incision) and the pt can feel the catheter under the skin.The removed segment of the left catheter was discarded at the time of the attempted removal.

Manufacturer Narrative

Method: the device is not available for return as the removed segment of the left catheter was discarded by the hospital.At the time of removal, the pt retained the broken segment of the catheter under the pt's skin.As a lot number was not provided, a review of the device history record (dhr) cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were preformed.For this reason results cannot be obtained.Conclusions: limited info was provided for the device.Multiple attempts were made to obtain additional info, however is not available, as the physician's office indicated that no further info will be available.The device was not returned to (b)(4) for eval, therefore we are unable to determine the cause for the reported event.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.

• Brand Name: ON-Q CATHETER
• Type of Device: CATHETERS
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, sutie 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4552872
• MDR Text Key: 5460082
• Report Number: 2026095-2015-00076
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: HEART VALVE; OTHER CONCOMITANT MEDICAL PRODUCTS: UNK
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 67