FDA Adverse Event
Injury
Summary report: N
ICROSS 40 MHZ CORONARY IMAGING CATHETER
MDR report key: 1368468
·
Received April 21, 2009
Report
- Report Number
- 2939204-2009-00307
- Event Type
- Injury
- Date Received
- April 21, 2009
- Date of Event
- March 12, 2009
- Report Date
- March 13, 2009
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT NUMBER WAS NOT PROVIDED; THEREFORE, MANUFACTURER AND EXPIRATION DATE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ANGIOGRAPHY AND ILEOFEMORAL INTERVENTION PROCEDURE, AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER DISTAL TIP DETACHED IN THE PT'S LEFT EXTERNAL ILIAC ARTERY. IT WAS NOTED THAT NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE IVUS CATHETER. THE DETACHED TIP WAS TOO SMALL TO BE RETRIEVED WITH A SNARE DEVICE, SO AN ATTEMPT TO PRESS THE DETACHED TIP AGAINST THE VESSEL WALL WITH A BALLOON CATHETER WAS TRIED UNSUCCESSFULLY. FINALLY, THE PHYSICIAN STENTED THE DETACHED TIP TO THE VESSEL WALL. PT WAS REPORTED TO BE DOING "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICROSS 40 MHZ CORONARY IMAGING CATHETER | CORONARY IMAGING CATHETER | DQO | BOSTON SCIENTIFIC CORP. | H749518050 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CORDIS/J&J - ATW GUIDEWIRE: UNK MANUFACTURER| 7F ANSEL I INTRODUCER SHEATH |