STEERABLE GUIDE CATHETER SGC0302

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for STEERABLE GUIDE CATHETER SGC0302 manufactured by Abbott Vascular.

Event Text Entries

[184448189] The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot. Based on the information reviewed, a conclusive cause for the reported pericardial effusion cannot be determined. The reported patient effect of pericardial effusion as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10


[184448190] This is being filed to report the pericardial effusion. It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4. One clip was implanted, reducing mr to 1-2. After the procedure, a pericardial effusion was noted at the right apex. The patient was monitored for 10 minutes and the effusion nearly disappeared. There was no clinically significant delay in the procedure and no adverse patient sequela. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02285
MDR Report Key9819933
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-02-24
Date Mfgr Received2020-02-24
Device Manufacturer Date2019-12-09
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005070406
Manufacturer Street3885 BOHANNON DRIVE
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal Code94025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTEERABLE GUIDE CATHETER
Generic NameVALVE REPAIR
Product CodeDRA
Date Received2020-03-11
Catalog NumberSGC0302
Lot Number91207U233
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-11

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