MAUDE Adverse Event Report: HALYARD - IRVINE SILVERSOAKER 2.5 IN CATHETER

Model Number PM010-A

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2015

Event Type  Injury  

Event Description

Procedure: total knee replacement cathplace: intra articular it was reported that during removal of a catheter the catheter broke inside the patient.The retained segment has not yet been removed; however, the x-ray results of the retained catheter piece are pending.Further clarification of the incident was received on (b)(6) 2015.It was reported that during removal of the catheter post-op day 3, there was resistance/difficulty met because the catheter was stuck inside of the patient's joint space.The nurse continued to pull on the catheter and the black tip of the catheter was retained inside the patient.The other portion of the catheter containing the other black mark appeared grayish and stretched out.It was also reported that it was difficult to estimate how much was left inside the patient and that the catheter was not sutured through.The patient did not experience any discomfort during the removal and the retained piece will not be removed at this time.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning and available for evaluation and analysis.At this time halyard is pending the receipt of the device.A review of the device history record (dhr) could not be conducted as a lot number was not provided.Results: the investigation and evaluation of this incident is in progress; therefore, results will be provided once they are completed.Conclusions: a follow-up report will be submitted once the investigation and sample evaluation have been completed.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 has not yet been received.

Manufacturer Narrative

Method: actual device was received, not fully intact, for an evaluation and investigation.A visual and microscopic inspection as well as a catheter tensile strength tests were performed.Results: a visual inspection found a silversoaker catheter returned.The silversoaker catheter was returned not fully intact, missing the black catheter tip.Evidence of attenuation was observed on the catheter.The catheter was examined under magnification and found signs of attenuation at the distal tip of the catheter where the black tip was missing.Further examination also found the hollow fiber bonding tubing of the catheter was broken in multiple places.The catheter was examined under magnification for brittleness and none was found.Tensile strength was performed on the silversoaker catheter and the catheter met specifications during the tensile test.The instructions for use (ifu) (14-60-602-0-04) specifies, "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." conclusions: the investigation summary concludes that the silversoaker catheter was received not fully intact missing the black catheter tip.Evidence revealed that attenuation was observed beginning after the third black marking and continuing down the remainder of the catheter.Attenuation was visible under magnification where the black tip was missing.The hollow fiber bonding tube was also found to have multiple breaks in it.Tensile strength was performed on the mid-body segment and infusion segment and met specifications.The root cause was determined to be incorrect use because attenuation was found and can be attributed to excessive force being used with the removal of the catheter.A technical bulletin, (mk-00021) preventing catheter breakage with on-q, 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: SILVERSOAKER 2.5 IN CATHETER
• 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: 4587787
• MDR Text Key: 5480079
• Report Number: 2026095-2015-00093
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

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: Physician
• Device Model Number: PM010-A
• Device Catalogue Number: 101353200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: ON-Q PUMP
• Patient Outcome(s): Other
• Patient Age: 60 YR