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	10/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
"traumatic brain injury patient implant the catheter, when connect with the cam02 monitor console, show with "no catheter connected", then after adjusting, show with "0", adjust again show with "-20", the catheter could not connect with cam02 monitor console successfully.When cam02 monitor connect with other camcabl, could work successfully." there was no death or serious injury reported and no medical intervention was required.Additional information has been requested.
Additional Manufacturer Narrative
Added 13 feb 2018: in response to an e-mailed request for further information related to the event, the following was received from the integra lifesciences representative in (b)(4) on 13 dec 2017: "operator of device" or, who was using it when the malfunction or injury was observed? (by profession such as "physician", med tech, etc.) physician.Was a user facility report submitted to us fda? no.Natus completed thier investigation 07 feb 2018.The investigation report provided by integra on 08 feb 2018 included or referenced: methods: evaluation of the actual device, review of device history records, review of complaints history, review of past capas/capa determination.The evaluation was unable to conclusively verify the complaint as valid.From the referenced "test inspection cam02" and "service order" reports provided from the evaluating facility ((b)(4)), the cable was inspected visually and it met acceptance criteria, it also was tested and found functional.No further review is deemed necessary; the product was investigated but the evaluation was unable to conclusively verify the complaint as valid, the camcabl was verified as performing to specification and not the cause of the complaint incident.Therefore, an investigation for cause was unable to be performed.The dhr was reviewed and no anomalies that could be associated with the complaint incident were observed, dhr record is attached.There is no service history for the device under evaluation.Based on the complaint evaluation performed a review of camcabl complaints was completed using the following key words "catheter not connect/connecting", "could not duplicate" in the search criteria.The review encompassed (b)(4) dates 06-feb-16 to 06-feb-18.A total of 33 complaints were reviewed of which this is the single complaint occurrence.Additionally the review verified this is the single complaint occurrence for the device under evaluation.A review of capa's initiated within the past 12 months, open capas and capa at voe 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 26-may-16 to 06-feb-18.A total of 3 capa's were reviewed of which none of the capa's scope were considered related to the complaint incident.Capa initiation is not required based on the complaint evaluation.The complaint could not be confirmed.The complaint is now deemed closed.

• 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: 7025172
• Report Number: 2023988-2017-00502
• Device Sequence Number: 13739285
• Product Code: GWM
• UDI-Device Identifier: 10381780039556
• UDI-Public: 10381780039556
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2017

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: Physician
• Device Model Number: CAMCABL
• Device Catalogue Number: CAMCABL
• Device Lot Number: TL-347881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1