FDA Adverse Event
Malfunction
Summary report: N
MULLINS TRANSSEPTAL CATHETER INTRODUCER SET - 8F
MDR report key: 1170307
·
Received September 12, 2008
Report
- Report Number
- 1220452-2008-00060
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 26, 2008
- Report Date
- August 29, 2008
- Manufacturer
- MEDTRONIC INC.
- Product Code
- DTB
- PMA / PMN Number
- K791963
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO US THAT THE INTRODUCER SHEATH BECAME TORN DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE INTRODUCER SHEATH INTO THE PATIENT. AT SOME POINT DURING THE PROCEDURE, THE GUIDE WIRE TIP WAS PROTRUDING THROUGH THE SIDE OF THE SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH, HOWEVER, THE MATERIAL BECAME TORN DURING REMOVAL. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE ALL OF THE DEVICE FROM THE PATIENT. THE PATIENT IS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULLINS TRANSSEPTAL CATHETER INTRODUCER SET - 8F | DTB | MEDTRONIC INC. | NA | 20043746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |