MAUDE Adverse Event Report: HALYARD - IRVINE SILVERSOAKER CATHETER

Device Problem Split (2537)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2015

Event Type  Injury  

Event Description

Procedure: laparotomy and hartmanns procedure.Cathplace: rectus sheath/preperitoneal.It was reported that a catheter break occurred during removal.It was reported as, "wound catheter snapped on trying to remove it".Additional information was received 05/12/2015.The catheter removal was performed on (b)(6) 2015 by the intensive care staff.During the catheter removal the catheter stretched and snapped; a catheter fragment was retained in the patient (distal 3-4cm).The distal black mark on the catheter was not seen upon removal of the catheter.It was reported that a decision was made to not perform additional medical intervention, at this point.At the time of this report the patient's condition is reported as stable.

Manufacturer Narrative

(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.The instruction 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 (figure 12 on page 2)." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.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 CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 2211 6; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4803505
• MDR Text Key: 5893524
• Report Number: 2026095-2015-00158
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/28/2015
• 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: TEGADERM DRESSING
• Patient Outcome(s): Other
• Patient Weight: 70