FDA Adverse Event
Malfunction
Summary report: N
JOURNEY GUIDEWIRE
MDR report key: 2071607
·
Received April 28, 2011
Report
- Report Number
- 2134265-2011-01609
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Report Date
- March 30, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- DQX
- PMA / PMN Number
- K081021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SAME CASE AS MFR: 2134265-2011-01610. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE TOTALLY OCCLUDED LESION WAS LOCATED IN A NON TORTUOUS AND HEAVILY CALCIFIED TIBIAL ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.0MM X 40MM STERLING ES BALLOON CATHETER ON TO THE 300CM JOURNEY GUIDE WIRE HOWEVER; NEAR THE END, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE BALLOON CATHETER AND GUIDE WIRE WERE REMOVED FROM THE PATIENT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON CATHETER AND A DIFFERENT GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOURNEY GUIDEWIRE | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC - MAPLE GROVE | M001391290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2.0MMX 40MM STERLING ES BALLOON CATHETER |