FDA Adverse Event Injury Summary report: N

CAMINO CATHETER, UNKNOWN

MDR report key: 6308103 · Received February 7, 2017

Report

Report Number: 2023988-2017-00019
Event Type: Injury
Date Received: February 7, 2017
Report Date: January 19, 2017
Manufacturer: INTEGRA NEUROSCIENCES CA/USA
Product Code: GWM
PMA / PMN Number: K102875
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 03/28/2017. THE INVESTIGATION INCLUDED: CONCLUSION: THE CUSTOMER DID NOT REPORT THE LOT NUMBER OR CATHETER ID NUMBER SO A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. ADDITIONALLY, BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE COULD BE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT. ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT DOES NOT ALLOW FOR CONFIRMATION OR DENIAL OF REASONABLY FORESEEABLE MISUSE OF THE CATHETER OR ACCESSORIES.

Description of Event or Problem · 1

DURING A WEB CHAT WITH AN INTEGRA LIFESCIENCES CUSTOMER SERVICE AGENT ON (B)(6) 2017, THE CUSTOMER STATED THAT THE TIP OF AN INTEGRA CAMINO ICP CATHETER CAME OFF IN A PATIENT. THE CUSTOMER INQUIRED IF THE TIP WAS MRI COMPATIBLE. WHEN THE INTEGRA LIFESCIENCES CUSTOMER SERVICE AGENT ASKED IF THE PATIENT WAS INJURED AND IF THE TIP BROKE, THE CUSTOMER RESPONDED WITH "NO. THE METAL SLEEVE ON TIP CAME OFF". THE INTEGRA LIFESCIENCES CUSTOMER SERVICE AGENT THEN TRIED TO OBTAIN ADDITIONAL INFORMATION AND FURTHER ASSIST THE CUSTOMER BY REQUESTING WHICH FACILITY THE CUSTOMER WAS AFFILIATED WITH AND HIS CONTACT INFORMATION. HOWEVER, THE CHAT SESSION ENDED. NO FURTHER INFORMATION COULD BE OBTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
90221	CAMINO CATHETER, UNKNOWN	N/A	GWM	INTEGRA NEUROSCIENCES CA/USA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other