MAUDE Adverse Event Report: HALYARD - IRVINE SILVER SOAKER CATHETER

Model Number UNKNOWN

Device Problem Split (2537)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: we are currently pending the receipt of the actual sample.However, the actual model and lot number were not provided.Therefore, a review of the device history record (dhr) cannot be conducted.Results: once the sample is received, testing will be performed and results will be provided.Conclusion: once the sample is tested and the investigation is completed, a follow-up report will be filed.This incident has been included in our complaint handling database for monitoring and trending.Pending return of the sample.

Event Description

It was reported that a catheter broke while removing from the patient, about 2 inches.At this time, it is unknown if the broken catheter will be removed or left in the patient.Additional information received on 9/18/15, the physician was successful in removing the retained portion of the catheter at the patient's bedside with no difficulty.Patient is in good condition.The sample is available for return, lot number is unknown at this time.

Manufacturer Narrative

(b)(4).Method: the actual device was received for analysis.A visual inspection and tensile strength test was performed.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: a visual inspection found that two catheters were returned with the pump.Two catheters were returned but only one will be tested.Per the complaint description, "said that they put the catheter in the intercostal space to create a block and it broke upon taking it out.Said that it's about 2 inches and that he sees 2 lines and then it broke.The first catheter came out fine." the catheter was returned not fully intact, in two pieces.The diameter where the breakage occurred was measured to be 0.025¿.The non-broken part was measured to be 0.043¿.The soaker catheter was examined under a microscope magnified at 0.7x, no signs of brittleness were observed.Tensile strength was performed on the catheter.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The result for the catheter mid-body segment was 9.26(lbf).The result for the infusion segment was 4.38(lbf).The catheter met specifications during the tensile test and no additional testing was performed.Conclusions: the investigation summary concludes that the catheter was received not fully intact.Evidence revealed that stretching was observed where the breakage occurred.Tensile strength was performed on the mid-body segment and met specifications.Excessive force failure mode was chosen because during visual observation of the catheter, stretching and breakage was observed.Tensile strength on the mid-body met specifications.Using excessive force >4.00(lbf) on the catheter at the mid-body segment and >2.8(lbf) at the infusion segment will cause it to break.Based on the investigation, an ifu and technical bulletin was sent to the customer to mitigate future incidences.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: SILVER SOAKER 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
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5154943
• MDR Text Key: 28729761
• Report Number: 2026095-2015-00270
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• 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 Age: 66 YR