FDA Adverse Event
Other
Summary report: N
4F-80CM PREM SYNTEL CATHETER
MDR report key: 2112611
·
Received April 6, 2011
Report
- Report Number
- 2027111-2011-00037
- Event Type
- Other
- Date Received
- April 6, 2011
- Date of Event
- March 23, 2011
- Report Date
- April 6, 2011
- Manufacturer
- APPLIED MEDICAL
- Product Code
- DXE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN, FOLLOW UP WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
EMBOLECTOMY PROCEDURE, ENDOVASCULAR TECHNIQUE- "THE PHYSICIAN COULD NOT PULL BACK THE CATHETER WHEN INFLATED. SO SHE TRIED TO PULL BACK WHEN DEFLATED AND HAD A LOT OF RESISTANCE AND WHEN THE CATHETER CAME OUT, SHE SAW THAT THE BALLOON AND SPIRAL REINFORCEMENT RUNNING UNDER THE BALLOON WHERE LOST IN THE PATIENT. THEY DON'T KNOW YET IF THEY ARE GOING TO REMOVE IT SURGICALLY OR LEAVE IT IN THE PATIENT. THE COMPLAINT SAMPLE WILL PARTIALLY BE RETURNED. REST IS IN BODY OF THE PATIENT." "UNKNOWN IF NEW MEDICAL OR SURGICAL INTERVENTION WILL BE REQUIRED. HAS NOT BEEN DECIDED YET."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4F-80CM PREM SYNTEL CATHETER | NONE | DXE | APPLIED MEDICAL | CE0480ST | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |