MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA COMPLETE BRAIN IMC-PROBE KIT: CC1.SB PROBE IM1 SINGLE LUMEN BOLT STERILE; LICOX BOLTS CATHETERS & KITS

Catalog Number IM1S

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A clinical trial administrator reported on behalf of the customer that the im1s complete brain imc-probe kit: cc1.Sb probe im1 single lumen bolt sterile was implanted on (b)(6) 2019 with a value of around 0.The device was not working after twenty four (24) hours.The device was removed on (b)(6) 2019.There was no adverse event.The potential cause was reported as a blood clot since there was blood when removing the probe.Complementary information was received on 23may2019 indicating that the physician thought that there could be some blood in the way of the probe which could explain it not working.There was nothing on the scanner and on the probe after removing it.He believed it might have been a probe issue.

Manufacturer Narrative

The licox probe ref cc1sb (part of ref im1s), lot 210216, sn (b)(4) was received.Probe was broken in 2 parts, its tip was still inserted in the introducer ref im1.Probe tip was sheared.Breakage occurred at the level of the compression seal.Introduction of a guidewire in im1 introducer showed a blockage at the level of the compression seal : examination of the components showed deformed parts, restricting the diameter inside the introducer.The device history records review did not reveal any anomaly that could explain the reported event.The complaint was verified, the probe was not functional.Breakage of the catheter was likely related to shearing of the probe and wires due to an excessive tightening of the compression cap.The device instructions for use caution to leave a 2mm distance between the compression cap and bolt wings: "hold the wings of the bolt with one hand while tightening the compression cap with the other hand.The distance between the wings of the bolt and compression cap is small when tight, approximately 2 mm".Device identifier im1s (b)(4).

• Brand Name: COMPLETE BRAIN IMC-PROBE KIT: CC1.SB PROBE IM1 SINGLE LUMEN BOLT STERILE
• 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
• MDR Report Key: 8686233
• MDR Text Key: 201940947
• Report Number: 9612007-2019-00032
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K002765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2019
• Device Catalogue Number: IM1S
• Device Lot Number: 0210216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1