MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED INTEGRA FIBER OPTIC CATHETER CABLE; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	CAMCABL
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
From e-mail forwarded by integra on 08 nov 2017: "catheter error when plugged into camino monitor.Need to have cable replaced.No patient injury, found during surgery, however, no delay." follow-up e-mail sent 13 dec 2017 for more information.
Additional Manufacturer Narrative
Additional information received from user facility- (b)(6) hospital medical center: was the failure found during installation/testing, prior to first patient use? yes.Was the product damage, missing/additional/wrong part found prior to system installation? no.Date complaint occurred: actual date that an event or issue took place (b)(6) 2017.(b)(6).Patient information: age, gender and weight of patient required.Unknown.Was there a delay in surgery due to product problem: if there was a delay in surgery indicate how long of a delay.Not necessarily; we had a second camcbl that we were able to open and use did the incident cause injury or death? no.Was a user facility report submitted to fda? no.Has it been return for investigation? if yes, please provide us the tracking number.Unsure.Natus completed the investigation on 06march2018.The investigation report provided by integra on 08march2018 included the following: methods: review of complaints history/ trend analysis.Review of past capas/capa determination.Device history and service history: the device history record could not be reviewed because the serial number was not provided.There is no service history for this device under evaluation.Based on the complaint description a review of camcabl complaints was completed using the following key words "catheter error" in the search criteria.The review encompassed (b)(4) dates (b)(6) 2016 to (b)(6) 2018.A total of (b)(4) complaints were reviewed of which this is the single complaint occurrence.A review of capa's initiated within the past 12 months, open capas and capa at (b)(4) was completed specifically related to the complaint was completed to determine if a similar complaint is either under active capa investigation or have been previously addressed through a capa.The review encompassed (b)(4) dates (b)(6) 2016 to (b)(6) 2018.A total of 3 capa's were reviewed of which none of the capa's scope were considered related to the complaint incident.The complaint could not be confirmed: the product was not returned and the evaluation was unable to be performed.The complaint is now deemed closed.If the product is returned for evaluation the complaint will be reopened and the evaluation will be completed accordingly.

• Brand Name: INTEGRA FIBER OPTIC CATHETER CABLE
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; ida business and technology pa; sragh tullamore, offaly ; EI
• MDR Report Key: 7121664
• Report Number: 2023988-2017-00512
• Device Sequence Number: 1260442
• Product Code: GWM
• UDI-Device Identifier: 10381780039556
• UDI-Public: 10381780039556
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K121573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CAMCABL
• Device Catalogue Number: CAMCABL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1