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.
[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
| Report Number | 3013394970-2020-00168 |
| MDR Report Key | 9908397 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-04-03 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THERESA MUSSAW |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 2837866718 |
| Manufacturer G1 | TERUMO PUERTO RICO LLC |
| Manufacturer Street | INNOVACION STREET LOT 21 CAGUAS WEST INDUSTRIAL PARK |
| Manufacturer City | CAGUAS, 00725 |
| Manufacturer Postal Code | 00725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS |
| Generic Name | DEVICE, HEMOSTASIS, VASCULAR |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 610133 |
| Lot Number | 06099037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 265 DAVIDSON AVE SUITE 320 SOMERSET, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |