MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA CAMINO ICP MONITORING CATHETER W/ INTEGRATED LIC; N/A

Catalog Number 1104L

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  Injury  

Event Description

A complaint for a camino catheter was reported with no mention of the product problem.Additional information was received on 26aug2015 with the following information: the catheter got stuck when they tried to remove it.When asked if there was any patient harm, it was reported that it was thought the tip of the catheter broke off in the patient's head but it seems like after checking the catheter, everything was still attached.The doctor said the image after the mri could have been a bone fragment.There was a delay in surgery (amount of time not reported).Additional information has been requested but to date, no new information has been received.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: evaluation of actual device review of device history records review of complaints history (b)(4) batch history records, which were released from (b)(6) 2015, show they met requirements prior to finished goods.Complaint history, model (b)(4), from (b)(6) 2014 through (b)(6) 2015 reviewed; current failure rate for similar complaints 0.02%.A review of the device history record did not reveal any anomalies observed during the manufacturing, packaging or inspection of the device or accessories while in process.Additional information received from the complainant does not allow for confirmation nor denial of reasonably foreseeable misuse of the catheter or accessories.Additionally, because the product was not returned for evaluation, no root cause established for the failure mode described in the customer complaint.

• Brand Name: CAMINO ICP MONITORING CATHETER W/ INTEGRATED LIC
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5082560
• MDR Text Key: 25992888
• Report Number: 2023988-2015-00032
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1104L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other