MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S HORIZONTAL/ VERTICAL LUMBAR VALVE SYSTEM; LUMBOPERITONEAL SHUNT, PRODUCT CODE

Model Number 903345A

Device Problems Material Fragmentation (1261); Device Issue (2379)

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

Event Date 05/04/2017

Event Type  malfunction  

Event Description

Three separate lumboperitoneal shunt system were opened due to defective implants.Catheter was tearing easily while dr bari was attempting to place the shunt.None of the implants were expired.Md requests that implants be further investigated.Two systems noted above were wasted.Patient came back at a later date and had removal of ventriculo peritoneal shunt and lp shunt, dr bari laparoscopic assisted lumboperitoneal shunt placement.Patient came back at a later date and had removal of ventriculo peritoneal shunt and lp shunt, (b)(6) laparoscopic assisted lumboperitoneal shunt placement.Cross reference medwatch report numbers 2023988-2018-00026 and 2023988-2018-00028.Additional information has been requested.

Manufacturer Narrative

After initial customer contact several attempts were made to obtain additional information, however additional information was not received: on 04may2018: request for additional information.On 01june2018: request for additional information.Natus completed their investigation on 20august2018.Investigation results included: evaluation of actual device.Review of device history records.Review of capas/ capa determination.Review of complaints history and complaint rate.Risk management review.The customer's complaint "catheter was tearing easily while dr bari was attempting to place the shunt" was confirmed.The evaluation for the returned device was performed by integra biot (the manufacturing site) the investigation findings are as follows: upon receipt of the defective product, it was found that the damaged tubing was in fact the tube inlet tubing of the hv body.(component b3160250c/ lot 187402).Dhr review: device history record of the lot# 187402 was reviewed on 1 1/06/2018 and no anomalies were found related the molding process or the controls performed the non-straight edge of the catheter allows affirming that the catheter was not damaged with a cutting tool like a scalpel during the deburring or assembly.Complaint verified.Nevertheless, the investigation did not reveal or allow understanding the origin of the problem.After reviewing the manufacturing file (b)(4) , the manufacturing process (molding assembly and packaging) and the inspections carried out, it is improbable that: the problem is due to the manufacturing the device was been shipped as is.Hypothesis-tearing may be due to the shunt implantation procedure by using a clamp without jaws covered with silicone elastomer tubing as preconised in the ifu, and the tearing could have progressed during the connection to the integrated connector of the antechamber.Capa: no capa issued from the last 24 months.Complaint history review/ trend analysis: based on the complaint description a review of complaints was performed using the following code and key words " perfoi 1, integra broken in use " in the search criteria.The review encompassed dates may2016 through may-2018.There is one (1 ) confirmed complaints during this time.Based on the number of sales (may-2016 through apr-2018), (b)(4) units, (b)(4).Risk management review: a review of the shunt systems and accessories product family-fmea-sss-sh-002 rev.01 identifies the hazard for the customers complaint as "device does not function as intended" (hazard id # (b)(4)).The harm being an "delay in patient treatment" with a severity of harm as moderate.Root cause: route cause could not be identified.The most plausible root cause is that the cuts and damages to the shunt were sustained during the shunt implantation procedure and the tearing potentially progressed during the connection to the integrated connector of the antechamber.No further action is required at this time however, customer complaints are monitored and reviewed during the quality management review for trends.This complaint is now deemed closed.

Manufacturer Narrative

After initial customer contact several attempts were made to obtain additional information, however additional information was not received: 04may2018: request for additional information.01june2018: request for additional information.Natus completed their investigation on (b)(6) 2018, investigation results included: evaluation of actual device.Review of device history records.Review of capas/ capa determination.Review of complaints history and complaint rate.The customer's complaint "catheter was tearing easily while dr bari was attempting to place the shunt" was confirmed.The evaluation for the returned device was performed by integra biot (the manufacturing site) the investigation findings are as follows: upon receipt of the defective product, it was found that the damaged tubing was in fact the tube inlet tubing of the hv body.(component b3160250c/ lot 187402) dhr review: device history record of the lot# 187402 was reviewed on 1 1/06/2018 and no anomalies were found related the molding process or the controls performed the non-straight edge of the catheter allows affirming that the catheter was not damaged with a cutting tool like a scalpel during the deburring or assembly.Complaint verified.Nevertheless, the investigation did not reveal or allow understanding the origin of the problem.After reviewing the manufacturing file188880, the manufacturing process (molding assembly and packaging) and the inspections carried out, it is improbable that: the problem is due to the manufacturing the device was been shipped as is.Hypothesis-tearing may be due to the shunt implantation procedure by using a clamp without jaws covered with silicone elastomer tubing as preconised in the ifu, and the tearing could have progressed during the connection to the integrated connector of the antechamber complaint history review/ trend analysis: based on the complaint description a review of complaints was performed using the following code and key words " perfoi 1, integra broken in use " in the search criteria.The review encompassed dates may-2016 through may-2018.There is one (1 ) confirmed complaints during this time.Based on the number of sales (may-2016 through apr-2018), 397 units, this complaint code (reason) has an incident rate of 0.251 0/0.Risk management review: a review of the shunt systems and accessories product family-fmea-sss-sh-002 rev.01 identifies the hazard for the customers complaint as "device does not function as intended" (hazard id # irfm-006a).The harm being an "delay in patient treatment" with a severity of harm as moderate.Root cause: route cause could not be identified.The most plausible root cause is that the cuts and damages to the shunt were sustained during the shunt implantation procedure and the tearing potentially progressed during the connection to the integrated connector of the antechamber.No further action is required at this time however, customer complaints are monitored and reviewed during the quality management review for trends.This complaint is now deemed closed.

• Brand Name: HORIZONTAL/ VERTICAL LUMBAR VALVE SYSTEM
• Type of Device: LUMBOPERITONEAL SHUNT, PRODUCT CODE
• Manufacturer (Section D): INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S; 2905 route des dolines; sophia antipolis, 06560 ; FR 06560
• MDR Report Key: 7561516
• MDR Text Key: 109901065
• Report Number: 2023988-2018-00027
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780035404
• UDI-Public: 10381780035404
• Combination Product (y/n): N
• PMA/PMN Number: K161992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 903345A
• Device Catalogue Number: 903345A
• Device Lot Number: 0188880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention