FDA Adverse Event
Malfunction
Summary report: N
OPENSAIL CORONARY DILATATION CATHETER
MDR report key: 332929
·
Received May 9, 2001
Report
- Report Number
- 2024168-2001-00134
- Event Type
- Malfunction
- Date Received
- May 9, 2001
- Date of Event
- April 10, 2001
- Report Date
- April 11, 2001
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- LOX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PTCA PROCEDURE OF THE "CTO" LESION IN THE RIGHT CORONARY ARTERY, THE 1.5MM BALLOON CATHETER WAS ADVANCED TO THE LESION, WHEN IT WAS NOTED THAT THERE WERE TWO BALLOON MARKERS. THE BALLOON CATHETER WAS REMOVED WITHOUT INFLATION AND THE POUCH OF THE DEVICE WAS CHECKED AND FOUND TO BE A 2.5MM BALLOON CATHETER. THE BOX AND THE POUCH WERE COMPARED AND THE PART/LOT NUMBER ON THE BOX WAS 1005280-20/0092652, THE PART/LOT NUMBER ON THE POUCH WAS 1005284-20/0092551. REPORTEDLY, THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21216 | OPENSAIL CORONARY DILATATION CATHETER | CORONARY DILATATION CATHETER | LOX | GUIDANT VASCULAR INTERVENTION | NA | 0092652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | CROSSIT 300, INFLATION DEVICE: ACS, GUIDING| DILATATION CATHETER: TEMPEST 1.5/20, GUIDE WIRE:| CATHETER: VIKING 6FJR4. |