FDA Adverse Event
Malfunction
Summary report: N
FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 8.5 F
MDR report key: 18554927
·
Received January 22, 2024
Report
- Report Number
- 3005334138-2024-00024
- Event Type
- Malfunction
- Date Received
- January 22, 2024
- Date of Event
- August 8, 2023
- Report Date
- April 10, 2024
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DYB
- PMA / PMN Number
- K894343
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PMA/510(K) #: K894343.
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED MATERIAL SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 0
DURING THE PROCEDURE, THE SHEATH DISCONNECTED FROM THE HUB AND WAS RETAINED UPON REMOVAL OF THE SHEATH.
Description of Event or Problem · 0
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE SHEATH DISCONNECTED FROM THE HUB AND WAS RETAINED UPON REMOVAL OF THE SHEATH. WEEKS LATER, THE PATIENT RETURNED, AND THE SHEATH WAS FOUND RETAINED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405841 | FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 8.5 F | CATHETER, INTRODUCER | DYB | ST. JUDE MEDICAL | 406707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Unknown |