MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q CATHETER; ELASTOMERIC PUMP

Model Number ASKU

Device Problem Split (2537)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Procedure: asku.Cathplace: asku.An international distributor relayed a report received from a customer in the united kingdom regarding a catheter that "snapped off during attempted removal from the wound".The sample is available for return.Additional information was received on 05/22/2015.The incident occurred during catheter removal.Additional information was requested, however is not available at this time.

Manufacturer Narrative

(b)(4).Method: the device was received 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.

Manufacturer Narrative

Methods: along with the previously reported method, microscopic inspection and catheter tensile strength testing were performed on the dual catheters.Results: silver-soaker catheter #1 was returned not fully intact, it was missing the black catheter tip.Evidence of stretching was observed throughout the infusion segment where the breakage occurred.The diameter of the breakage part was measured to be 0.021¿.The non-attenuated part was measured to be 0.043¿.The silver-soaker catheter was examined under a microscope and there were no signs of brittleness observed.Tensile strength testing was performed on silver-soaker catheter #1.The results for the catheter's mid-body segment was 10.75(lbf) and the results for the infusion segment was 9.22(lbf).The catheter met specifications during the tensile strength testing.Silver-soaker catheter #2 was returned fully intact.No damages were observed on the catheter.The catheter's diameter was measured to be 0.044".The silver-soaker catheter was examined under a microscope and there were no signs of brittleness observed.Tensile strength testing was performed on the silver-soaker catheter #2.The results for the catheter's mid-body segment was 9.36(lbf), and the infusion segment was 4.56(lbf).The catheter met specifications during tensile strength testing.The instructions for use (ifu) provides a warning, "placing the 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." in addition, the ifu specifies, "caution if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.¿ do not cut or forcefully remove catheter." conclusions: the investigation summary concluded that silver-soaker catheter #1 revealed that stretching was observed at the location of the breakage.The catheter (#1) was tested for tensile strength on both the infusion segment and mid-body segment and the catheter met specifications.Catheter #2 was examined, it was found to be fully intact with no damages observed on the catheter.The catheter (#2) was tested for tensile strength on both the infusion segment and mid-body segment and the catheter met specifications.Based on the evidence that was observed throughout the infusion segment on catheter #1 where the breakage occurred, it was determined that excessive force was used in an attempt to remove the catheter.In addition, it was reported that there was a possibility that the catheter may have been sutured in; this may have caused or contributed to the reported event.Based on this investigation, the complaint is confirmed that excessive force caused the catheter to break likely due to being sutured in place and not stopping when the catheter stretched.A technical bulletin "tips for preventing in-situ catheter breakage with the on-q* pain relief system" and an additional catheter ifu were sent to the customer.An historical review indicated that no other complaints were received that were associated with this lot number.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
• Type of Device: ELASTOMERIC PUMP
• 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: 4835511
• MDR Text Key: 5947060
• Report Number: 2026095-2015-00165
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/10/2015
• 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