MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA; CHPV WITH SG

Catalog Number NS9008

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the valve was implanted via l-p shunt.An implant date and initial setting is unknown.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Around (b)(6) 2019, cerebral ventricular enlargement was observed at the contrast radiography.Then, the patient presented the orientation disorder and a fracture of the distal catheter was confirmed with mri.Also, the valve was unable to change the setting.Therefore, it was replaced with a new valve on (b)(6) 2019.No further information was provided by the hospital.

Manufacturer Narrative

The valve was received for evaluation.Review of the history device records for the valve, product code ns9008, with lot 139939, conformed to the specifications when released to stock.Manufacturing date june 1, 2017.Expiration date may 31, 2022.Failure analysis - the valve was visually inspected; no defects were noted.The valve passed the test for occlusion, leaks, reflux, siphon guard, pressure.The valve was tested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The siphon guard was removed, the cam mechanism was moved and the valve was tested again for programming, the valve passed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the ruby ball, on the seat of the ruby ball, on the cam mechanism and on the base plate.The root cause for the programming issue was due to biological debris found on the cam mechanism and on the base plate.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted donna engleman, director of regulatory programs, office of product evaluation and quality and michelle rios, assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: SPECIAL DEVICE UNITIZED PROGRA
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10292564
• MDR Text Key: 202930755
• Report Number: 1226348-2020-00416
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: NS9008
• Device Lot Number: 139939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR