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 2020-03-31 for PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM 12673-03 manufactured by Abbott Vascular.
[187717784]
The device was returned; however, investigation has not yet begun. A follow-up report will be submitted with all additional relevant information. The additional proglide devices are being filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[187717785]
It was reported that suture placement in the right common femoral artery was attempted with proglide devices using the pre-close technique via a 6f sheath prior to an aorta stent interventional procedure. The sutures of two proglide devices were successfully pre-placed. The sheath was upsized to 14f and the aorta stent interventional procedure was completed. Reportedly, at time of closure, a suture break occurred with the sutures of the second device pre-placed. Wire access remained and a third device was deployed; however, at the time to remove the device, it became stuck surgery was performed to remove the device. It was noticed the device was broken but still held together by the actuator wire. Hemostasis was achieved via surgical suturing. There was no reported adverse patient sequela and no reported clinically significant delay in the procedure or therapy. No additional information will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03184 |
| MDR Report Key | 9908592 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-09-28 |
| 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 | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM |
| Generic Name | SUTURE MEDIATED CLOSURE |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 12673-03 |
| Catalog Number | 12673-03 |
| Lot Number | 8092841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |