PRUITT AORTIC OCCLUSION CATHETER 2100-12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2013-05-24 for PRUITT AORTIC OCCLUSION CATHETER 2100-12 manufactured by Lemaitre Vascular.

Event Text Entries

[3462055] The pt in this case was under emergency care for a ruptured suprarenal aaa. The physician requested the aortic occlusion catheter. The required pre-use check of the device was not conducted. The device was placed in the pt and the balloon would not stay inflated to occlude the vessel. The physician used a traditional clamp and subsequently repaired the vessel. The pt was stabilized. The physician finished the procedure and the pt left the operation room. The pt later expired in the icu. We were not able to get confirmation from the physician as to whether the failure of the pruitt aortic occlusion catheter contributed or not to the death of this pt. We therefore are submitting this report based on the regulations set forth in 21 cfr 803. 56.
Patient Sequence No: 1, Text Type: D, B5


[10686861] We have received the complaint device for eval. We were able to verify and confirm the failure. We have found that the balloon had holes and was degraded. The root cause of balloon degradation remains inconclusive. However, sometimes signs of degradation appear before shelf life expiration due to storage conditions (the heat, light and/or humidity experienced by the packaging and the device prior to use). Since natural rubber latex is acted on by environmental conditions, we always recommend storage of our products in a cool dark area away from fluorescent lights, sunlight and chemical fumes to prevent premature deterioration of the rubber balloon (please ref lemaitre vascular, inc ifu for more details). Lot history records review did not reveal any discrepancies related to the complaint event during either the manufacturing or the packaging processes. Please note that the physician confirmed that the pre-use check was not conducted. The ifu requires the conduct of a pre-use check to verify that the balloon is functional and not leaking.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220948-2013-00007
MDR Report Key3138098
Report Source04,06,07
Date Received2013-05-24
Date of Report2013-04-18
Date of Event2013-04-16
Date Mfgr Received2013-04-18
Date Added to Maude2013-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street63 2ND AVENUE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7812212266
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRUITT AORTIC OCCLUSION CATHETER
Generic NamePRUITT AORTIC OCCLUSION
Product CodeDQT
Date Received2013-05-24
Returned To Mfg2013-04-19
Model Number2100-12
Catalog Number2100-12
Lot NumberPAO1099
Device Expiration Date2014-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR
Manufacturer AddressBURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other 2013-05-24

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