FDA Adverse Event
Malfunction
Summary report: N
CATH-LAB SHEATH INTRO SET
MDR report key: 3162491
·
Received June 6, 2013
Report
- Report Number
- 9680794-2013-00024
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 15, 2013
- Report Date
- June 5, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DYB
- PMA / PMN Number
- K924607
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CATH LAB DURING INSERTION. WHEN INSERTING THE SHEATH AT THE INSERTION SITE, THE HUB OF THE DILATOR CAME OFF. AS A RESULT, THE DEVICE WAS NOT USED. A NEW KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY NOTED. THE PATIENT OUTCOME IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251215 | CATH-LAB SHEATH INTRO SET | INTERVENTIONAL PSI PRODUCTS | DYB | ARROW INTERNATIONAL INC | CF1106763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |