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

Model Number G44130

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: principal quality engineer.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that while using a cook ventricular drainage catheter, cerebrospinal fluid leaked around the catheter where the stitches were placed.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Event Description

In additional information received on 17sep2020, the customer reported that the leaking of the catheter was discovered intra-operatively.It was also reported that the leak was "from the skin exit site and had nothing to do with the connections".

Manufacturer Narrative

E1: distributor reported to cook that the customer was dr.Neil feldstein at morgan stanley children¿s hospital.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation prasanna celestine from medtronic sofamor danek informed cook on (b)(6) 2020 of an incident involving a ventriclear drainage catheter set [rpn: 50318] from lot number ns13037539.Dr.Neil feldstein at morgan stanley children¿s hospital informed medtronic of this incident.On (b)(6) 2020 during an unknown procedure it was reported that the doctor felt that the product had changed in the last couple of months.There had been leaking of cerebrospinal fluid around the catheter where the stitches are placed.They also noted that it felt like a new softer material.Additional information received reporting that the leak was from the skin exit site and had nothing to do with the connections and the leaking occurred during intra-operatively.No unintended section of the device remained inside the patient¿s body.It is unknown if there were any adverse effects to the patient and what actions were taken as a result of the leaking.A review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could take place.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify the failure mode prior to distribution.A review of the design history file (dhf) found that the risks associated with this device are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot ns13037539 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there was one other complaint associated with this lot number for the same customer at the same time.The complaints are for unrelated failure modes.As there are adequate inspection activities established, objective evidence that the dhr was fully executed and no nonconformances.It was concluded that there is no evidence that nonconforming product exists in house or in field.A supplier investigation was requested, as the affected component is supplied to cook from medtronic.It was confirmed with the physician that the leak occurred from the skin exit site and had nothing to do with the connections.As the device was discarded by the customer, analysis of the product could not be performed.Medtronic stated that there were no material changes made to the catheter related to this failure.The instructions for use (ifu), provides the following information related to the reported failure mode: device description: -¿the ventriclear ii ventricular drainage catheter is impregnated with antimicrobial agents minocycline and rifampin, which may reduce the risk of catheter colonization and catheter-related infection during use.The activity of these antimicrobial agents is localized at the catheter surface and is not intended for treatment of ventriculitis¿ -¿inspect contents of this set for damage.If product is damaged, do not use.¿ precautions: -¿the product is intended for use by physicians trained and experienced in neurosurgery.Standard techniques for placement of ventricular catheters should be employed.¿ -¿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 rubbershod forceps when handling the catheter to prevent tearing or cutting the catheter.¿ instructions for use: -¿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.¿ how supplied: -"store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, examination of the returned product and the results of our investigation, it was concluded that the cause of this event was traced to an unintended user error.The ifu states ¿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.¿ if the customer did not use the holes of the silicone winged tie-down provided in the set, then the physician may have punched a hole in the material of the catheter.If the customer did not provide slack in the catheter when securing the silicone winged tie-down, then this may have put pressure on the catheter¿s shaft.The ifu also states ¿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 rubbershod forceps when handling the catheter to prevent tearing or cutting the catheter.¿ if the catheter was handled off-label, then this could create a tear in the shaft of the catheter.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 10547141
• MDR Text Key: 207373342
• Report Number: 1820334-2020-01703
• Device Sequence Number: 1
• Product Code: NHC
• UDI-Device Identifier: 00827002441309
• UDI-Public: (01)00827002441309(17)220210(10)NS13037539
• Combination Product (y/n): Y
• PMA/PMN Number: K160223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: G44130
• Device Catalogue Number: 50318
• Device Lot Number: NS13037539
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1