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

Model Number 903345A

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

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

Event Type  malfunction  

Event Description

Three separate lumboperitoneal shunt system were opened due to defective implants.Catheter was tearing easily while (b)(6) 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, (b)(6) 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 2023988-2018-00027 and 2023988-2018-00028.Additional information has been requested.

Manufacturer Narrative

Customer reported incident date as (b)(6) 2018, however the date appears to be incorrect as complaint was reported on (b)(6) 2018.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 31august2018.Investigation results included: evaluation of actual device.Review of device history records.Review complaints history and complaint rate.Risk management review.Review of capas/ capa determination.The customer complaint "three separate lumboperitoneal shunt system were opened due to defective implants catheter was tearing easily while dr (b)(6) was attempting to place the shunt" was confirmed.An evaluation of the returned value (without other components) found the sst connector sutured on the white tubing outlet.There was also tissue present with the suture and traces of what appears to be blood inside the silicone body.The extremity of the inlet catheter was found ripped.There is also a cut present on the end of the catheter, a mark (most likely left by a suture) is visible on the outlet side of the stripped peritoneal catheter and the suture hole of the body is cut.The value appears to have been implanted.Dhr review: the dhr for the device was reviewed and no anomalies that could be associated with the complaint incident were observed, the device met all specification prior to release.Based on the location of the cut and the presence of sutures it is most likely that the device was damaged while in use.Complaint history review/ trend analysis: based on the complaint description a review of complaints was performed using the following key word 'perfoi 1, integra broken in use " in the search criteria.The review encompassed dates may-2016 through may-2018.There was 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 lumboperitoneal shunt system risk management file mdha-sss-sh-ooi rev 01 identifies the hazard for the customers complaint as "tip of catheter comes off (irretrievable device fragment)" (hazard id # ill-j-006).The harm being an "injury requiring surgical intervention" with a severity of harm as serious.This incident result is scored as follows: severity rate: serious.Rate of occurrence: remote.Risk level: provisionally acceptable.Per rba-sss-sh-ooi rev 01 : residual risk/benefit analysis: the tip of the comes off (irretrievable device fragment); injury requiring surgical intervention, inflammation: local toxicity; systematic toxicity.Failure modes are identified in the product application (1) fema that individual residual risk is "provisionally acceptable".Medical professional generally understands and exercise care during the insertion or removal of the catheter to avoid damaging it.Instructions for use generally warn against withdrawing the catheter with the tuohy needle.Stare of the art for catheters for this intended use requires similar design and construction techniques.Therefore, based on the available data and information, the provisionally acceptable individual residual risk does represent state-of-the-art in risk control for products of this type and is acceptable at this time.It has been determined that the products in the shunt system and accessories product families are safe and effective for the intended use, and that the medical benefits attained from the use of the devices are judged to outweigh the overall residual risks.Capa: n/a- no capa issued within the last 24 months.Root cause: n/a- could not be identified-the most plausible root cause is that the cuts and damages to the shunts were sustained during the shunt implantation procedure and the tearing potentially progressed during the connection to the integrated connector of the antechamber.Did device likely contribute to reported incident or adverse event? unable to determine based on the evaluation and incident rate, no further action is required at this time.Customer complaints are reviewed during the quality management review meetings to monitor/ identify any adverse trends.This complaint is now deemed closed.

• Brand Name: HORIZONTAL/ VERTICAL LUMBAR VALVE SYSTEM
• Type of Device: LUMBOPERITONEAL SHUNT
• Manufacturer (Section D): INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S; 2905 route des dolines; sophia antipolis, 06560 ; FR 06560
• MDR Report Key: 7561523
• MDR Text Key: 109907555
• Report Number: 2023988-2018-00026
• 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
• 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: 02/28/2019
• Device Model Number: 903345A
• Device Catalogue Number: 903345A
• Device Lot Number: 194257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention