MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) DSF2233 manufactured by W.l. Gore & Associates.
[188886061]
On (b)(6) 2020 the patient underwent endovascular treatment of a distal aortic arch aneurysm using a gore? Dryseal flex sheath as an accessory in the procedure. The gore? Dryseal flex sheath was reportedly inserted from the patient's left femoral artery. Implantation of the treatment device was successfully performed. The origin of the patient's left subclavian artery was coil embolized as previously planned. During the embolization procedure, bleeding from the valve of the gore? Dryseal flex sheath was observed. The amount of blood loss was reported as approximately 200cc. The physician clamped the valve, and transfusion was performed. The procedure was continued and completed with no further reported issues. During closure of the access site, the gore? Dryseal flex sheath was investigated. The valve was pressurrized with no issue, and there was no saline leakage noted. The physician concluded that the valve was inadvertently hit by the physician's upper arm during the embolization procedure, the valve was unintentionally unlocked, and bleeding occurred as a result. The clinical sales associate reported that, due to inspection of the sheath and to the reported information from the physician, there was no malfunction of the gore? Dryseal flex sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00076 |
| MDR Report Key | 9879387 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-25 |
| Device Manufacturer Date | 2019-12-12 |
| Date Added to Maude | 2020-03-25 |
| 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 | JENNA LOPEZ |
| 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 | 2020-03-25 |
| Model Number | DSF2233 |
| Catalog Number | DSF2233 |
| Lot Number | 21569871 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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; 2. Required No Informationntervention | 2020-03-25 |