FDA Adverse Event
Other
Summary report: N
ICROSS 40 MHZ CORONARY IMAGING CATHETER
MDR report key: 1477950
·
Received September 17, 2009
Report
- Report Number
- 2939204-2009-00735
- Event Type
- Other
- Date Received
- September 17, 2009
- Date of Event
- September 3, 2009
- Report Date
- September 3, 2009
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED.
Description of Event or Problem · 1
AN INTRAVASCULAR ULTRASOUND (IVUS) IMAGING CATHETER WAS USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO IMAGE THE LESION PRIOR TO STENT PLACEMENT. THE LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), WAS CALCIFIED, VERY TIGHT AND NOT TORTUOUS. DURING WITHDRAWAL OF THE IVUS CATHETER, THE PT EXPERIENCED SUBSTERNAL CRUSHING CHEST PAIN. THE REPORTED PAIN RESOLVED UPON DEVICE REMOVAL AND THE PHYSICIAN PROCEEDED TO PLACE STENT AND POST DILATE. THE IMAGING CATHETER WAS NOT USED AGAIN. PT STATUS WAS REPORTED TO BE "OKAY".
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 | 57 YR | Other |