ANGIOVAC 25186 H965251860

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-21 for ANGIOVAC 25186 H965251860 manufactured by Angiodynamics.

Event Text Entries

[176269798] It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. An investigation into the root cause of this incident is currently in progress. The results of the investigation will be sent via a follow up medwatch. Complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[176269799] As reported: angiovac (av, generation 2) case with material in the rv. Adhered to the wall. Non mobile. Almost obstructing the rvot. No pre-case planning or images were reviewed before the procedure. Both surgeon and i were unavailable to pre-case plan. I received a text late the night before on new years day about the case and it was scheduled for first thing in the morning. This was the doctors second/third case. Patient has a history of cancer along with other comorbidities. Previous surgeries cabg x4 (18 years ago) (b)(6) male. The patient did not want to have open heart surgery again. Once tee probe was inserted we discussed the case. His goal was to debulk as much as possible. I explained the difficulties of the case with concerns about crossing the valve and set expectations low for the procedure due to the appearance and location of the mass that it would not be likely that this would be a successful case. Surgeon discussed his plan for the case which was to place a wire across the tricuspid valve, through the rvot and into the pa and go on pump in the rv to get out as much material as possible. Access points were 26f gds sheath through the rij and return in the lfv. Access was gained, small sheaths were placed and heparin was given. Lfv small sheath was upsized to a 17fr return and wet to wet connections to our circuit which was primed and lines were separated. Rij was upsized to a 26fr gds. Soft wire into the pa through the gds. Jr4 diagnostic cath was placed, soft wire removed and stiff lunderquist (260cm) was placed through the jr4 and into the pa. Suture was also placed into one pedal, distal tip of the av closest to the inside aspect of the 20 degree angle for steerability. Av device was then placed over the wire into the rv. Obturator was taken out but wire stayed in during the procedure. Flows were between 1. 5-2. 5l. Angiovac was advanced to the material and the material was engaged. No material visualized in the tubing or in the bubble trap. During this time the patients blood pressure dropped, pt had a few brief moments of vtach, as well as bradycardia. They came off pump a few times because of this. The next move was to take av out and place av with obturator all the way up into the pa take obturator out, go on pump and slowly walk the av back from pa, rvot to rv and debulk the mass that way. Wire remained in at all times. At this time patients blood pressure dropped, brief moments of vtach and bradycardia. No material was removed after the aforementioned repositioning of the cannula. They decided to go back in one more time. Av was placed through the tv over the wire a third time and again patients blood pressure dropped and became bradycardic. At this point the patient coded. Cpr was started and meds were given. After 10 mins the finally got the patient back. Tee now showed a torn cord. Material was still in the rv and they decided to end the procedure. It was reported the defective disposable device is not available for return to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1317056-2020-00002
MDR Report Key9611618
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-21
Date of Report2020-02-10
Date of Event2020-01-03
Date Mfgr Received2020-01-03
Date Added to Maude2020-01-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAW RYAN
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS, NY NY 12801
Manufacturer CountryUS
Manufacturer Postal12801
Manufacturer Phone5187424488
Manufacturer G1ANGIODYNAMICS
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS, NY NY 12801
Manufacturer CountryUS
Manufacturer Postal Code12801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANGIOVAC
Generic NameCATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS
Product CodeDWF
Date Received2020-01-21
Returned To Mfg2020-01-20
Model Number25186
Catalog NumberH965251860
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS
Manufacturer Address10 GLENS FALLS TECHNICAL PARK GLENS FALLS, NY NY 12801 US 12801


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-01-21

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