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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that a 0.5 cm portion of the tip of a ventriclear drainage catheter fractured during placement of the device and was retained.The patient was operated on four days later, and the fragment was retrieved successfully.No further information is currently available.Additional information has been requested from the customer.It is unknown if the complaint device will be returned; as of the date of this report, no device has yet been received for evaluation.

Manufacturer Narrative

Investigation - evaluation: a review of the complaints history, drawings, documentation, instructions for use (ifu), quality control, manufacturing, and specifications of the returned device were conducted during the investigation.Per the user facility form, it was marked that the device was available for evaluation.It was also noted that ¿pictures were sent to the manufacturer.¿ however, no pictures were received from the complainant and the device was not returned for evaluation.The manufacturer inquired multiple times to gain additional information from the complainant, and no additional information or communication was able to be provided.Thus, the results of the investigation will be based upon the information available from the user facility form.Because the lot number could not be provided, the device history record could not be reviewed.It cannot be determined whether this was the only failure on this device¿s lot.Furthermore, search of our complaint management system revealed only two other complaints detailing a similar failure.Although the proper manufacturing documents are in place, without the work order it cannot be determined whether the reported device was manufactured to specification.Because the device was not returned, a representative device from a previous complaint with a similar failure mode was referenced.Similar to the reported incident from the complainant, the incident discusses how the ventricular catheter broke into two pieces during insertion.Despite an additional supplier investigation on the returned device, it was unable to be determined with certainty what led to the device¿s failure.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.This failure mode has been escalated per internal processes.We will continue to monitor for similar complaints and have notified the proper personnel about this event.

Event Description

The customer reported that a 0.5 cm portion of the tip of a ventriclear drainage catheter fractured during placement of the device and was retained.The patient was operated on four days later, and the fragment was retrieved successfully.No further information is currently available.Additional information has been requested from the customer.It is unknown if the complaint device will be returned; as of the date of this report, no device has yet been received for evaluation.It should be noted this mdr was created from information obtained from user facility form 3500a reference: (b)(4).Further review of the record/event identified that the according to the user facility form, the fracture occurred during removal of the drainage catheter not during placement as previously reported (reported in error).It was also noted this event occurred in (b)(6) of 2017, the exact date is unknown to the manufacturer.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7126857
• MDR Text Key: 95165987
• Report Number: 1820334-2017-04452
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 50318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 04/04/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 5 YR