• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG Back to Search Results
Catalog Number 823162
Device Problem No Flow (2991)
Patient Problem Failure of Implant (1924)
Event Date 07/07/2021
Event Type  Injury  
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 Description
A physician reported a hakim valve was implanted to a patient via v-p shunt on (b)(6) 2020 with 100mm2o.The patient is a (b)(6) female patient with a primary disease of a brain tumor.The set pressure was gradually reduced to 30 and the ventricles size did not changed.The contrast medium was passing.When the physician checked the valve the pressure was high but it was not flowing,.Therefore, valve was removed on (b)(6) 2021 and replaced to strata(medtronic).The patient is in stable condition.
 
Event Description
N/a.
 
Manufacturer Narrative
The hakim valve was returned for evaluation.Device history record (dhr): the product code 823162 with lot 3334632 conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; a small cut/tear in the silicone housing on the siphon guard was noted and a scratch in the silicone housing was noted near the proximal connector, as well as needle holes in the needle chamber.The position of the cam when valve was received was 120mmh2o.The valve was hydrate.The valve was leak tested and only leaked from the needle hole in the needle chamber no leakage was noted from the cut/tear in the silicone housing over the siphon guard.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.The root cause for the cut/tear/scratch in the silicone housing is probably due to wrong handling, as noted in the ifu: silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.No leakage was noted from the damaged silicone housing at the time of investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROG VALVE INLINE W SG
Type of Device
CHPV WITH SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ 
MDR Report Key12289053
MDR Text Key265428293
Report Number3013886523-2021-00356
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K041296
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/29/2021
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
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue Number823162
Device Lot Number3334632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Initial Date Manufacturer Received 07/15/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received09/14/2021
Supplement Dates FDA Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age9 YR
-
-