FDA Adverse Event
Injury
Summary report: N
WIRE, GUIDE, CATHETER
MDR report key: 3861401
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07131
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 10, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- DQX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE SYSTEM UPGRADE PROCEDURE, WHILE USING A DEFLECTABLE CATHETER, A SMALL DISSECTION OF THE MIDDLE CARDIAC BRANCH OCCURRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338777 | WIRE, GUIDE, CATHETER | DQX | MEDTRONIC PUERTO RICO OPERATIONS CO. | MDT-CATHETER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R |