MAUDE Adverse Event Report: COOK INC VENTRICLEAR DRAINAGE CATHETER SET; NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)

Catalog Number 50318

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.[hhs_fda_3500a_(b)(4).Pdf].

Event Description

The user facility reported an issue associated with a ventriclear drainage catheter set on report (b)(4).Cook inc.Received the report notification on 17aug2018.As reported, a patient with a posterior fossa mass status post craniotomy for tumor resection underwent ventriculostomy catheter removal.During the procedure, a 3.2 cm portion of the distal tip of the external ventricular drain fractured and was retained.The retained segment was later removed in the operating room.To date, despite several good faith attempts, additional information has not been provided by the customer.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Additional information/corrected data e3-occupation: patient safety coordinator device evaluation the complaint device was not returned; therefore, no physical examinations could be performed; however, a similar product experiencing a similar failure mode was selected from a previous complaint for review.The previous complaint did not have a product returned to the manufacturer, however, pictures were obtained.The pictures clearly indicated the device snapped into two pieces.A device failure analysis was completed by the supplier, stating, ¿both edges at the tear site appear to be jagged.The returned segments were patent and passed leak testing when tested individually.Proteinaceous debris was observed within the interior and exterior of the catheter.¿ it was unable to be determined with certainty what led to this failure mode.This failure mode was escalated per internal processes.For the current complaint, a document based investigation evaluation was performed.Investigation a document-based investigation reviewed the following: drawing, instructions for use, manufacturing instructions, and quality control specifications clinical assessment: at this time, the most probable causes of this event are human anatomy, device failure, user technique or medical procedure related.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Per the ifu: warnings "- this device is not intended for permanent implantation.- the ventricular catheter may become obstructed by particulate matter such as blood clots, brain fragments, or other tissue particles, or by excessive reduction of ventricle size.- occasionally, fibrous adhesions will bind the catheter to the adjacent choroid plexus or brain tissue.Gentle rotation may free the catheter.Under no circumstances should the catheter be forcefully removed.If the catheter cannot be removed without force, it is advisable to allow it to remain in place, rather than risk intraventricular hemorrhage." precautions "- inspect contents of this set for damage.If product is damaged, do not use.- refer to manufacturer¿s instructions when using accessory components other than cook products.- exercise caution when placing and using the catheter to prevent contact with bare fingers, talc, towels, or any lint-bearing surfaces that could contaminate the catheter surface and cause tissue reactions.- the catheter should not come into contact with ethyl alcohol, isopropyl alcohol, or other alcohols, acetone or other non-polar solvents.These solvents may remove the antimicrobials from the catheter and reduce the catheter¿s antimicrobial activity.- kinking of catheter tubing may result in restricted flow or damage to the catheter.- the catheter should be secured with non-metallic sutures in such a manner as to avoid cutting or occluding the tubing.The use of stainless steel ligatures on silicone products is not recommended.- use rubber shod forceps when handling the catheter to prevent tearing or cutting the catheter." instructions for use "[¿]3.Position the catheter into the ventricular space using the pre-loaded stylet within the catheter.[¿] 5.Verify proper positioning of catheter using ct or other imaging modality, being careful not to disturb catheter¿s position.[¿] 7.Push the tunneling device through the scalp, taking care not to dislodge the intraventricular portion of the catheter.Push the tunneling device and catheter subcutaneously until the desired exit site is realized.The catheter can be held in place with a rubbershod hemostat or forceps while tunneling.8.After exiting the skin, pull the catheter through the subcutaneous tunnel until the catheter no longer protrudes from the incision site.Do this with great care to ensure the position of the catheter within the ventricle is not affected.Cut the catheter from the tunneling device.9.Trim the distal end of the catheter to size, cutting off the portion of the catheter that was crimped or damaged.Slide snap-fit cap (small end first) over the proximal end of the catheter.Attach the proximal end of the catheter to the barbed end of the female luer lock connector.Secure the catheter to the tapered hub of the luer lock adapter by sliding the snap-fit cap over the barbed portion of the adapter.Avoid cutting or occluding tubing.10.Suture the incision at the catheter exit site.Suture the catheter to the skin using the holes in the silicone winged tie-down.Provide some slack in the catheter when securing the silicone winged tie-down to offer strain relief to the catheter.The slack will compensate for patient movement.Cover the entire area with a sterile dressing.11.Cap the catheter with the red sterile luer plug or connect to a sterile drainage system for fluid collection.Follow directions carefully for connection and use of the drainage system utilized.12.Ensure the catheter remains capped or connected to a sterile drainage system at all times.All catheter or patient manipulations and fluid drainage system changes must be carried out utilizing strict sterile technique to reduce the risk of catheter-related infections." how supplied "upon removal from package, inspect the product to ensure no damage has occurred.¿ supplier investigation 1.Details of the investigation, including; a) description of the failure mode it was reported the catheter fractured and was retained.The retained segment was then removed in the operating room.B) methods used to perform the investigation (for example: review of lot/batch records, testing, examination of product, etc.) and results the product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.C) determination if product is out of specification the product was unavailable for return.Therefore an evaluation of the device performance was not possible.D) the relationship, if any, of the device to the reported event the product was unavailable for return.Therefore an evaluation of the device performance was not possible.E) if nonconforming product has been identified in house or in the field based on the investigation a review of the manufacturing records was not possible as no lot number was provided.2.Summary of the investigation and risk assessment, including; a) assessment of root cause the product was not returned for analysis; therefore, we were not able to determine the root cause of the reported event.B) any action taken by the manufacturer as a result of the event and risk assessment.No adverse trends have been identified associated with this product and type of event.We will continue monitor and trending these events.Conclusion based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, additional escalation was recommended and the appropriate measures have been initiated to address this failure mode.The appropriate personnel have been notified of this event and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: VENTRICLEAR DRAINAGE CATHETER SET
• Type of Device: NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7861457
• MDR Text Key: 119725091
• Report Number: 1820334-2018-02630
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• PMA/PMN Number: K071640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50318
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR