FDA.reportPublic FDA data

MAUDE MDR 9762533

MDR report key
9762533
Report number
2245270-2020-00011
Event key
0
Event type
3
Date of event
2020-02-10
Date received
2020-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
FREDA LACROIX
Address
2750 MORRIS ROAD LANSDALE, PA US
Phone
473-473-4735
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEADER-CATHINTRAVASCULAR CATHETERVYGONDQO115.090115.0908094298 OR 8095049* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2701. R

Event Narratives#

N

Patient 1

THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION. THE BATCH REVIEW OF THIS BATCH SHOWS THAT THE PRODUCT IS COMPLIANT TO ITS SPECIFICATION. THE TENSILE STRENGTH IS CONFORM TO ISO NORM.

D

Patient 1

PATIENTS ARTERY SCANNED, DEVICE STILL IN SITU IN RADIAL ARTERY, ADVICE SORT FROM VASCULAR CONSULTANT. PATIENT REVIEW BY VASCULAR CONSULTANT (B)(6) 2020 DUE TO THE PATIENTS POOR CLINICAL CONDITION NO FURTHER ACTION IS REQUIRED AND THE RETENTION OF THE ARTERIAL LINE IS UNLIKELY TO HAVE A DIRECT IMPACT ON THE PATIENT. THE PATIENT IS FRAIL AND ELDERLY POST HEMIARTHROPLASTY SURGERY AND HAS COGNITIVE IMPAIRMENT WITH LACK OF ABILITY TO RETAIN SHORT TERM MEMORY. THE ORTHOPAEDIC TEAM HAVE BEEN ASKED TO ENSURE THAT THE RETAINED OF THE PART IS CLEARLY OUTLINED WITHIN COMMUNICATION TO THE PATIENTS GP AND THE REASON TO LEAVE THE REMAINING PART IN SITU. THE PATIENTS NOK HAVE BEEN SPOKEN TO AND ARE AWARE OF THE IMPACT TO THE PATIENT AND THE ADVICE OFFERED FROM THE VASCULAR TEAM.