MAUDE Adverse Event Report: RAYNHAM PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823832

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that on (b)(6) 2019 a (b)(6) was implanted.On (b)(6) 2019, the patient appeared with subcutaneous hydrops, and during a ct check, it was found that the position of the valve was abnormal.On (b)(6) 2019, the patient had a revision surgery to retrieve the product and it was found that the spacer of the valve was dislodged.The valve was replaced with a same like product.No surgical delay reported.

Manufacturer Narrative

Review of the history device records for the valve, product code 82-3832 with lot 203970, conformed to the specifications when released to stock failure analysis: the valve was visually inspected: the needle guard was missing, not returned with valve.The valve passed the tests for programming, reflux, siphon guard.Could not be tested for occlusion, leak and pressure due to missing needle guard.The root cause could not be determined, as the needle base was not returned for investigation the silicone show¿s no sign of damage around the needle guard base.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 (b)(4) 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 (b)(6), director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9348927
• MDR Text Key: 189882801
• Report Number: 1226348-2019-00536
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 203970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1