MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q CATHETER SILVERSOAKER 1IN (2.5CM)

Model Number PM030-A

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Procedure: total knee replacement ((b)(6) 2015).Cathplace: incisional.It was reported that an incident of a catheter stretching and breaking occurred.It was reported as, "a catheter was removed and appears stretched and potential remained fragments".The device is available for return.Additional information was received on (b)(4) 2015.It was reported that during the removal of the catheter by nursing student instructor, the catheter broke and appeared stretched.An x-ray was taken on (b)(6) 2015 for further evaluation of the possible retained catheter.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Device return anticipated.

Manufacturer Narrative

Methods: the device was previously reported to be returning for an evaluation; however, it has subsequently been reported that the device will not be returned.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.The instructions for use (ifu) specifies the following: "warning: place catheter such that obstruction will not occur and catheter removal will not be impeded.Prior to final suturing, make sure catheter moves freely to ensure it¿s not caught in sutures.Assure that catheter is not in a vein or artery.Cautions: if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.It¿s advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again.The patient¿s body movements may relieve the catheter to allow easier removal.For additional information refer to the technical bulletin: tips for preventing in-situ catheter breakage with the on-q system.Do not cut or forcefully remove catheter.After removal, check distal end of catheter for black marking to ensure entire catheter was removed." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.A technical bulletin (mk-00021) tips for preventing in-situ catheter breakage was sent to the customer.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: ON-Q CATHETER SILVERSOAKER 1IN (2.5CM)
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD-IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4654791
• MDR Text Key: 21565133
• Report Number: 2026095-2015-00125
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

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 Model Number: PM030-A
• Device Catalogue Number: 101353700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2015
• 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