FDA Adverse Event
Injury
Summary report: N
AIM INNER CATHETER
MDR report key: 1955817
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-01088
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 1, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DQY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. CANCELLED PROCEDURE.
Description of Event or Problem · 1
DURING AN IMPLANTING PROCEDURE WHEN THE CATHETER WAS INSERTED INTO THE CORONARY SINUS IT COULD NOT ADVANCE. A CHEST X-RAY AND ECHOCARDIOGRAM REVEALED CARDIAC PERFORATION. THE CATHETER WAS REMOVED AND THE PATIENT'S CONDITION REMAINED STABLE. THE PHYSICIAN RECOGNIZED THAT IT WAS PROCEDURE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIM INNER CATHETER | ACCESSORY | DQY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 410148 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |