MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) DSF2433 manufactured by W.l. Gore & Associates.
[188887256]
A udi number is not available. Dyb / introducer, catheter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188887257]
Following was reported to gore. On (b)(6) 2020, a patient underwent a treatment of acute debekey iiib aortic dissection with gore? Tag? Conformable thoracic stent graft with active control system and gore? Dryseal flex introducer sheath. Although a resistance was felt when the dsf2433 was inserted into the left femoral artery, the procedure was continued. A vessel damage at external iliac artery was confirmed upon removing the dsf2433 after three ctags were placed. An excluder iliac extender component was placed to repair the vessel damage. The patient tolerated the procedure. The physician reported that the patient's blood pressure did not increase during the procedure, therefore, there was a possibility that the small bleeding was occurred during procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00081 |
| MDR Report Key | 9901000 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Device Manufacturer Date | 2018-09-18 |
| Date Added to Maude | 2020-03-30 |
| 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 | RACHAEL CHASCSA |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 1 B/P |
| Manufacturer Street | 32360 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-30 |
| Catalog Number | DSF2433 |
| Lot Number | 18594658 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-30 |