MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN; REGIONAL ANESTHESIA

Model Number	UNKNOWN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Procedure: femoral nerve block.A report was received stating an echospark catheter sheared off during needle removal.About 8 cm of the catheter with the catheter tip was retained inside the patient.The procedural physician called the company representative and asked what should be done with the broken catheter retained inside the patient.The company representative explained that the decision would have to be made by the physician.The breakage occurred when the catheter was thread into place and the needle was being removed.It is not known if there was any stretching.The product is a t-bloc tray with a touchy needle.After the catheter breakage, the physician attempted to locate the catheter remnant inside the patient using ultrasound.It could not be seen using ultrasound.At the time of this report, a decision had not been made on the next action regarding removal of the remnant.Additional information was received 16-feb-2017 stating the catheter remnant was removed from the patient.Additional information was received 21-feb-2017 stating the catheter for this complaint was removed when the patient was taken to surgery for the scheduled procedure.The patient had a femoral nail placement procedure related to a fracture.There were no complications.There was no reported injury.
Additional Manufacturer Narrative
One sample device was returned.A visual inspection found one catheter was returned.The complaint sample was identified as an echospark catheter.Only a portion of the distal end of the catheter was returned.The catheter appeared to be sheared.Unable to perform tensile strength on catheter segment due to its short length.The root cause could not be determined, since the sample was not adequate for testing.All information reasonably known as of 19-may-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

• Brand Name: UNKNOWN
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6397209
• Report Number: 2026095-2017-00041
• Device Sequence Number: 10772847
• Product Code: BSO
• UDI-Device Identifier: 10680651407945
• UDI-Public: 10680651407945
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2017

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
• Operator of Device: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: 0202502425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 05/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 75