FDA.reportPublic FDA data

MAUDE MDR 9706536

MDR report key
9706536
Report number
2134265-2020-01285
Event key
0
Event type
3
Date of event
2020-01-22
Date received
2020-02-13
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
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMAGER II ANGIOGRAPHIC CATHETERCATHETER, INTRAVASCULAR, DIAGNOSTICBOSTON SCIENTIFIC CORPORATIONDQO38265382650000133448Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-130

Event Narratives#

N

Patient 1

DEVICE EVAL BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS INSPECTED FOR ANY DAMAGE. THE DEVICE WAS RETURNED IN THE OPENED STERILE POUCH STILL IN THE CARDBOARD TABS. IT WAS NOTICED THAT THE DEVICE SHOWED A BROKEN SHAFT IN 1 LOCATION AND A SEPARATION IN ANOTHER LOCATION. THE BREAK WAS APPROXIMATELY 4CM FROM THE TIP AND THE SEPARATED PORTION WAS APPROXIMATELY 3CM FROM THE TIP. THE SEPARATED PORTION WAS NOT RETURNED. THE DEVICE AS MANUFACTURED IS 100CM LONG, THERE WAS A TOTAL OF 97CM RETURNED WHICH EQUALS TO 3CM OF THE TIP THAT WAS NOT RETURNED. THERE WAS 1 KINK NOTICED ON THE SHAFT LOCATED APPROXIMATELY 20CM FROM THE STRAIN RELIEF. NO OTHER DAMAGE WAS NOTICED ON THE DEVICES SHAFT. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE ON THE BOX, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

D

Patient 1

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JAN2020. AN IMAGER II/5/PIGTAIL/100/038 BX5 ANGIOGRAPHIC CATHETER RETURNED WITH NO KNOWN COMPLAINT. DEVICE ANALYSIS FOUND THE TIP WAS SEPARATED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED IN A PROCEDURE. THE DEVICE WAS TESTED AT THE HOSPITAL WAREHOUSE AND WAS FOUND TO BE FRACTURED.