FDA Adverse Event
Injury
Summary report: N
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
MDR report key: 2080537
·
Received April 22, 2011
Report
- Report Number
- 3003681312-2011-00024
- Event Type
- Injury
- Date Received
- April 22, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 21, 2011
- Manufacturer
- ST. JUDE MEDICAL PUERTO RICO, B.V.
- Product Code
- MGB
- PMA / PMN Number
- P930038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED A PT HAD A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE AND AN ANGIO-SEAL WAS SELECTED FOR USE. WHEN THE DEVICE WAS BEING PULLED BACK, THE DEVICE COMPONENTS CAME OUT OF THE PT. BLEEDING FROM THE PUNCTURE SITE WAS OBSERVED AND MANUAL COMPRESSION WAS APPLIED. THE PT WENT INTO SHOCK WHILE MANUAL COMPRESSION WAS BEING APPLIED. THE PT WAS TREATED WITH THE FOLLOWING MEDICATIONS: ATROPINE (DOSAGE UNK) AND INFUSIONS (DOSAGE UNK). THE PT WAS REPORTED TO STABLE AFTERWARDS. ADDITIONAL INFO WAS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP | ANGIO-SEAL DEVICE | MGB | ST. JUDE MEDICAL PUERTO RICO, B.V. | NA | 3229337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |