MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA SHUNT TUNNELER; VALVE ACCESSORIES

Model Number	990010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Keratitis (1944); Paresis (1998); Confusion/ Disorientation (2553)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that during ventriculo-peritoneal shunt placement, the shunt tunneler (990010) handle was stuck.The surgeon had to break the plastic handle to continue the procedure.There was risk of injury for the patient and for the surgeon during breakage/disassembly of the handle.Facility also stated there was a risk of pneumothorax due to the possible 2nd implantation of tunneler.Additional information received indicates there was increased surgery time of 15 minutes and that the patient was hospitalized in neurosurgery department with fluctuating temporal-spatial disorientation and tetraparesis during rehabilitation.He also has left eye corneal abscess due to exposure keratitis.The 2nd implantation of tunneler was avoided by the surgeon.
Additional Manufacturer Narrative
Additional information: facility has advised that the plastic protection could be removed normally.Investigation findings: shunt tunneler (990010) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Without device to investigate, complaint is deemed unverifiable and its exact root cause undetermined.A possible cause of blocked handle of the malleable tunneler could be related to a too short polyamide thread length (if the thread could not be removed, which was not the case as confirmed by user), or related to excessive force with rotation applied on the handle when inserted in the patient (leading to deform the cannula at the handle level, blocking it).If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: SHUNT TUNNELER
• Common Device Name: VALVE ACCESSORIES
• 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13902051
• Report Number: 9612007-2022-00008
• Device Sequence Number: 19893716
• Product Code: GYK
• UDI-Device Identifier: 10381780034414
• UDI-Public: 10381780034414
• Combination Product (Y/N): N
• PMA/510(K) Number: K932273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2024
• Device Model Number: 990010
• Device Catalogue Number: 990010
• Device Lot Number: 0225941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/21/2022
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male