MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q CATHETER SILVERSOAKER 10IN (25CM)

Model Number PM040-A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Procedure: nuss procedure.Cathplace: chest.An incident of a catheter break was reported.It was reported that a catheter broke inside of a pediatric patient during removal by an anesthesiologist.Approximately 10-12 inches of the catheter broke inside of the patient.Due to the nature of the procedure performed, the broken catheter cannot be removed for 2 years, in order to avoid disturbing the rods that were placed in the patient's chest.The anesthesiologist has opted to leave the catheter in for 2 years.Additional information was requested, however is not available at this time.It was not reported if the device fragment is available for return.

Manufacturer Narrative

(b)(4).Method code:(b)(4).Actual device not evaluated 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 instructions for use (ifu) (14-60-602-0-04) specifies the following: "warnings do not suture through catheter to avoid catheter breakage during removal.Remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter.1.Remove dressing and loosen the adhesive strips at catheter site (figure 10 on page 2).2.Grasp catheter close to skin and gently pull to remove.The catheter should be easy to remove and not painful.Do not tug or quickly pull on catheter during removal (figure 11 on page 2).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.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.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.

Manufacturer Narrative

Methods: along with the previously reported method, a tensile strength test and a microscopic examination were performed.Results: a visual inspection found that a silversoaker catheter was returned not fully intact, missing the black catheter tip and infusion segment.Evidence of stretching 2.7¿ at the 1st markings was observed and also observed throughout the entire catheter.The non-stretched part was measured to be 0.039¿ and the stretched part was measured to be 0.021¿.The catheter was examined under a microscope with no signs of brittleness observed.Tensile strength testing was performed on the catheter.The catheter met specifications during the tensile strength test.Conclusions: the investigation summary concluded that the catheter was received not fully intact, missing the black catheter tip and infusion segment.Evidence revealed that stretching was observed where the breakage occurred.Tensile strength tests was performed on the mid-body segment and met specifications.It was determined that incorrect use may have contributed to the reported incident, due to the evidence that stretching was observed where the breakage of the catheter occurred.Additionally, it was reported that a 5/5 resistance was met when removing the catheter.As previously reported, the instructions for use (ifu) specifies, "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)." an instructions for use (ifu) (14-60-602-0-04) and a technical bulletin, preventing catheter breakage, were sent to the customer.In a continuous effort to improve, a broken catheter complaints awareness training has been implemented.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.

Manufacturer Narrative

Method: it was previously reported that the device was not available for return, however the device was returned for analysis.A visual inspection was performed.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation 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.

Event Description

Date of surgery: (b)(6) 2015.The patient did not experience discomfort during the catheter removal; however, 5/5 resistance was met during removal.The catheter thinned and broke between the first marking after black tip and the single marking that follows.The patient's condition is reported as stable and the patient denies pain.

• Brand Name: ON-Q CATHETER SILVERSOAKER 10IN (25CM)
• 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.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4889408
• MDR Text Key: 6073101
• Report Number: 2026095-2015-00184
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2015

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: PM040-A
• Device Catalogue Number: 101353900
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/30/2015; 09/10/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 45