FDA Adverse Event
Malfunction
Summary report: N
SKATER INTRODUCER SYSTEM
MDR report key: 9788709
·
Received March 4, 2020
Report
- Report Number
- 1625425-2020-00202
- Event Type
- Malfunction
- Date Received
- March 4, 2020
- Date of Event
- January 16, 2020
- Report Date
- February 20, 2020
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- GCB
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE SAMPLE DEVICE FOUND THE COIL WAS STRIPPED OFF THE GUIDEWIRE, CONFIRMING THE CUSTOMER''S COMPLAINT. CAPA C-2020-009 HAS BEEN INITIATED TO ADDRESS THE ISSUE OF GUIDEWIRE DETACHMENT. H3 OTHER TEXT : PLACEHOLDER.
Additional Manufacturer Narrative · 1
THE SAMPLE DEVICE IS INDICATED AS AVAILABLE FOR EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT THE DEVICE HAS NOT YET BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED BY 4/3/2020.
Description of Event or Problem · 1
DURING PLACEMENT OF A DRAINAGE CATHETER, THE DISTAL COIL OF THE 0.018¿ GUIDEWIRE SUSPECTED STRIP OFF THE CORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253350 | SKATER INTRODUCER SYSTEM | SKATER INTRODUCER | GCB | ARGON MEDICAL DEVICES INC. | 11271397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |