FDA Adverse Event
Injury
Summary report: N
LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH SET
MDR report key: 4060337
·
Received August 25, 2014
Report
- Report Number
- 2522007-2014-00013
- Event Type
- Injury
- Date Received
- August 25, 2014
- Date of Event
- July 21, 2014
- Report Date
- August 25, 2014
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- DRE
- PMA / PMN Number
- K061000
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
THREE-LEAD EXTRACTION; 2 LEADS REMOVED SUCCESSFULLY. THIRD LEAD BROKE INSIDE PT AND COULD NOT USE NEEDLES EYE SNARE DUE TO AMOUNT OF VEGETATION. DOCTOR DECIDED FOR THORACOTOMY LATER. THE PT HAD LOW BLOOD PRESSURE BUT WAS STABLE. THEY CHECKED WITH ULTRASOUND AND PLACED A PERICARDIAL DRAIN. AFTER SURGERY, THEY DISCOVERED A PUNCTURE IN THE AURICULA. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513483 | LEAD EXTRACTION EVOLUTION SHORTIE MECHANICAL DILATOR SHEATH SET | NONE | DRE | COOK VASCULAR INC. | N116844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L |