MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2006-08-24 for PERICARDIOCENTESIS PROCEDURE KIT PC 100/A manufactured by Merit Medical Systems, Inc..
[532155]
During a pericardiocentesis procedure performed in a hospital, the complainant reported that the clinican had difficulty removing the guide wire from the catheter. The catheter and guidewire were removed together, and a new pericardiocentesis catheter was placed in the patient. The event did not result in injury or harm to the patient or end users.
Patient Sequence No: 1, Text Type: D, B5
[7837041]
Device return is anticipated. A failure investigation will be conducted. Once additional information is available, it will be included in a follow-up to this report and forwarded to the agency. Note: merit's sales representative in france failed to report this event promptly to merit's returned goods authorization department, resulting in a delay in filing this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628221-2006-00019 |
| MDR Report Key | 755452 |
| Report Source | 01,06,07 |
| Date Received | 2006-08-24 |
| Date of Report | 2006-08-23 |
| Date of Event | 2006-06-16 |
| Date Mfgr Received | 2006-06-19 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEPHANIE ERSKINE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERICARDIOCENTESIS PROCEDURE KIT |
| Generic Name | PERICARDIOCENTESIS KIT W/PIGTAIL CATHE |
| Product Code | DOR |
| Date Received | 2006-08-24 |
| Model Number | NA |
| Catalog Number | PC 100/A |
| Lot Number | F421264 |
| ID Number | NA |
| Device Expiration Date | 2008-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743283 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | * WEST JORDAN UT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 6 | 1. Life Threatening | 2006-08-24 |