FDA.reportPublic FDA data

MAUDE MDR 9702289

MDR report key
9702289
Report number
2126666-2020-00010
Event key
0
Event type
3
Date of event
2020-01-16
Date received
2020-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JACKIE OHNSORG
Address
340 LAKE HAZELTINE DRIVE CHASKA, MN US
Phone
641-641-6418
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PREFORM GUIDEWIRE - SAFARI2WIRE GUIDELAKE REGION MEDICALDQXH74939406S139406S111143492R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1201. O

Event Narratives#

N

Patient 1

A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. REVIEW OF THE DIRECTIONS FOR USE LISTS THE REPORTED EVENT AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. SHOULD ADDITIONAL INFORMATION BE PROVIDED OR PRODUCT BE RETURNED FOR ANALYSIS A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

D

Patient 1

EVENT DESCRIPTION: PER (B)(6), IT WAS REPORTED THAT: ON EVENT DATE, DURING INDEX PROCEDURE, A SAFARI EXTRA-SMALL CURVE WIRE WAS ADVANCED INTO THE LEFT VENTRICULAR CAVITY, POST WHICH SUBJECT DEVELOPED BRADYCARDIA AND THE SUBJECT WAS PACED AT 65 BPM.