8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS N/A 610133

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 2020-03-31 for 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS N/A 610133 manufactured by Terumo Medical Corporation.

Event Text Entries

[188850543] Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device was not returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record of the product code/lot# combination was conducted with no findings. This report is for the second device used on the patient; see mdr 3013394970-2020-00167 for the first device reported on the same patient.
Patient Sequence No: 1, Text Type: N, H10


[188850544] The user facility reported that the angio-seal locator/insertion sheath assembly was attempted to be inserted into the puncture site, but the assembly was not inserted because the tip of the assembly was kinked. The device was replaced with another angio-seal device to continue the procedure, but the locator/insertion sheath assembly was kinked at the same part and could not be inserted. The second device was replaced with a competitor's device, which was able to be inserted into the puncture site without problem. Subsequently, hemostasis was successfully achieved by the third device. Angiography revealed that there was no calcification, and the physician used the devices properly. The estimated blood loss was less than 250cc's. There was no health damage to the patient. The procedure before deploying the device was carotid artery stenting (cas). A pre-deployment angiogram was performed. The size of the sheath ancillary used was 8 fr. It is unknown whether the puncture site was distal or proximal to the inguinal ligament of the right common femoral artery. The vessel diameter is unknown. There were no other devices or equipment used with the reported product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013394970-2020-00168
MDR Report Key9908397
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-02
Date Mfgr Received2020-04-03
Device Manufacturer Date2019-10-23
Date Added to Maude2020-03-31
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 ContactTHERESA MUSSAW
Manufacturer Street950 ELKTON BLVD.
Manufacturer CityELKTON, MD
Manufacturer CountryUS
Manufacturer Phone2837866718
Manufacturer G1TERUMO PUERTO RICO LLC
Manufacturer StreetINNOVACION STREET LOT 21 CAGUAS WEST INDUSTRIAL PARK
Manufacturer CityCAGUAS, 00725
Manufacturer Postal Code00725
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS
Generic NameDEVICE, HEMOSTASIS, VASCULAR
Product CodeMGB
Date Received2020-03-31
Model NumberN/A
Catalog Number610133
Lot Number06099037
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO MEDICAL CORPORATION
Manufacturer Address265 DAVIDSON AVE SUITE 320 SOMERSET, NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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