MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN CATHETER; CATHETERS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Transient loss of all brainstem reflexes; deeply anesthetized.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 28-jul-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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

A complaint was received stating a literature piece was identified that reports a catheter being placed inadvertently.The article is a technique paper from the university of utah and was published in 2016.The catheter was inadvertently placed subdurally.The patient required extended ventilator support due to being deeply anesthetized.After one hour recovered without residual effects.The article is titled: postoperative pain control with the fentanyl patch and continuous paravertebral anesthetic infusion after posterior occipitocervical junction surgery.Pertinent excerpts from the article pertaining to the event is provided as follows: product: on-q painbuster catheter system.In regards to complications at our facility, there have been no cases of respiratory depression or arrest postoperatively and no wound infections, but one case of inadvertent subdural placement.Continuous anesthetic delivery devices have been in use at our institution in general surgery, vascular surgery, orthopedic spine surgery, and occipitocervical junction and spine surgery since 2009.The on-q catheter was placed in a caudal to rostral direction.This patient remained deeply anesthetized for one hour postoperatively requiring continued ventilatory support, and there was a transient loss of all brainstem reflexes, including nonreactive dilated pupils, but no hemodynamic instability.After one hour, the patient awakened and recovered fully with no residual impairment.Postoperatively, the wound was monitored for a csf leak, and there was no evidence of a pseudomeningocele or clinical evidence of intracranial hypotension.The risk of this complication can be avoided if the depth and trajectory of catheter insertion are carefully controlled and also if a rostral-caudal insertion path is used.The most common problem with the on-q system in this application has been premature pull-out of one or more catheters or significant percutaneous drug leakage at the insertion site, requiring earlier than intended catheter removal.In one early case where inadvertent intradural passage with a catheter placed in a caudal to rostral direction and bupivacaine infusion occurred, no permanent injury resulted, although there was a prolonged emergence from anesthesia.

• Brand Name: UNKNOWN CATHETER
• Type of Device: CATHETERS
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6757973
• MDR Text Key: 81562835
• Report Number: 2026095-2017-00142
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention