MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for FOGARTY ARTERIAL EMBOLECTOMY CATHETER 120804F manufactured by Edwards Lifesciences Pr.
[186027647]
Attempts are being made to obtain further information and the product in question. The complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation results if received. A review of the manufacturing records indicated that the product met specifications upon release. Udi # (b)(4) - mw5092344.
Patient Sequence No: 1, Text Type: N, H10
[186027648]
It was reported that a 4 fr fogarty embolectomy catheter was being used by the surgeon during an av fistula declot procedure. During the procedure, the entire end of the catheter including the entire balloon portion sheared off while in the patient. It was unable to be retrieved by the surgeon. Edwards lifesciences was notified of this event by a (b)(4) report. Attempts have been made to obtain additional information from the facility but the facility has not responded to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10993 |
| MDR Report Key | 9843050 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-04-03 |
| Date Added to Maude | 2020-03-17 |
| 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 | MRS LYNN THOMAS |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 ANASCO |
| Manufacturer City | PR |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOGARTY ARTERIAL EMBOLECTOMY CATHETER |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-17 |
| Model Number | 120804F |
| Catalog Number | 120804F |
| Lot Number | 62104839 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |