MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER; LICOX BOLTS CATHETERS & KITS

Catalog Number IP2P

Device Problem Crack (1135)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not returned evaluation.The device history records were reviewed and did not reveal any anomaly that could explain the reported event.The reported complaint was not confirmed.Root cause could not be determined with the available information.

Event Description

It was initially reported on 20aug2018 by a sales representative on behalf of the customer that the ip2p (kit containing cc1.P1 and the ip2 introducer) was placed by an intensivist and it was cracked at insertion on an unspecified date.There was patient contact but there was no patient injury and no known delay in surgery.Additional information had been requested but no further information was provided.On 30nov2018, medwatch form with uf/importer report number: (b)(4) was received with the following information: the licox was placed on a (b)(6) patient and drainage was noted by the registered nurse (rn).Physician was notified, who stated the device was cracked.Date of event was reported as (b)(6) 2018.Another catheter was placed.

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
• Type of Device: LICOX BOLTS CATHETERS & KITS
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8190534
• MDR Text Key: 131215274
• Report Number: 9612007-2018-00039
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K040235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IP2P
• Device Lot Number: 0207872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Date Device Manufactured: 05/01/2018
• 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 Age: 17 YR