MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER; N/A

Catalog Number IP1P

Device Problems Device Inoperable (1663); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  Injury  

Event Description

The licox probe did not work; incoherent value (stable at 1 mmhg whatever ptio2 was).Position of the probe was checked during scanner and was okay.There was a delay in monitoring.Another device was used.Additional information received on 14june2017: monitoring was delayed for 24 hours.No major impact on the (b)(6) female patient.

Manufacturer Narrative

Investigation completed 8/22/2017.Licox cc1p1 probe sn 016 was received screwed in the ip1 introducer.The probe was connected to the licox cmp monitor (n° rat0119) and showed a value of zero mmhg (instead of around 150mmhg).Visual inspection showed the compression cap was too tightly connected to the bolt.The instructions for use clearly specify that distance between the wings of the bolt and compression cap is approximatively 2mm.Removal of the probe from the bolt showed a deformation of the internal components inside the introducer narrowing the pathway, and a breakage of the suture thread (maintaining components).The narrowed pathway does not allow anymore the guidewire insertion (while the device is provided with the guidewire inserted).The licox probe removed from the introducer showed a fracture at the level of the compression cap: under magnification, the probe looks twisted and sheared.Although after disassembly the probe is broken in two parts, inspection showed the presence of electrolyte in the protective sheath, in the sensitive area of the catheter, and in the probe.Electrical continuity between the connector and the probe part including the anode/cathode was verified, excluding any issue with the connector.The device history records review of ip1p lot 0201077 did not reveal any anomaly.The batch was manufactured in april 2017 and included 8 products.Two complaints were received in june 2017 from the same hospital for this lot: one reported incoherent o2 values, one no value read.A review of integra complaints tracking database for ip1p , cc1p1, it2, it2eu, ip2p (kits containing cc1p1) reveal a (b)(4) rate of complaints for measuring problems.Three cases were reported in 2014, seven in 2015, five in 2016, three in 2017: no trend is observed.The complaint is verified and the cause of the non-functional probe is linked to an over- tightening (using excessive force) of the compression cap on the bolt.This over-tightening could have been prevented by strictly operating according to the ifu : the section ¿tightening of the compression cap¿ includes a paragraph saying ¿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".

• Brand Name: KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER
• Type of Device: N/A
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6683898
• MDR Text Key: 78914728
• Report Number: 9612007-2017-00019
• 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: foreign,health professional,u
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IP1P
• Device Lot Number: 0201077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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): Required Intervention
• Patient Age: 48 YR