FDA Adverse Event
Injury
Summary report: N
PRECLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
MDR report key: 1171315
·
Received September 22, 2008
Report
- Report Number
- 2953144-2008-01525
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- August 26, 2008
- Report Date
- August 28, 2008
- Manufacturer
- ABBOTT VASCULAR REDWOOD CITY
- Product Code
- MGB
- PMA / PMN Number
- P960043
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EXPECTED TO BE RETURNED FOR EVAL. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.
Description of Event or Problem · 1
DEVICE MALFUNCTION: CUFF MISS. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY,WHEN THE NEEDLE PLUNGER WAS REMOVED, A NEEDLE TIP DID NOT CAPTURE A CUFF. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM | MGB | ABBOTT VASCULAR REDWOOD CITY | NA | 67157-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |