MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2005-10-06 for PERICARDIOCENTESIS PROCEDURE KIT PC101 manufactured by Merit Medical Systems, Inc..
[485473]
During a pericardiocentesis procedure, the physician inserted an. 038" guide wire through an 18gx15cm needle, which was already inserted in the pt's pericardial sac. Resistance was encountered when removing the needle over the guide wire. The dilator was inserted over the guide wire without any complication. Upon insertion of the drainage catheter, resistance was met, and the catheter remained "stuck" on the middle of the guide wire. Upon attempting to remove the guide wire, resistance was encountered, and both the catheter and guide wire were pulled out. The procedure was successfully completed using another pericardiocentesis kit. There was no reported short-term or permanent pt impairment as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628221-2005-00023 |
| MDR Report Key | 715666 |
| Report Source | 01,08 |
| Date Received | 2005-10-06 |
| Date of Report | 2005-09-13 |
| Date of Event | 2005-09-13 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-05-19 |
| 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 | 8012084349 |
| Manufacturer G1 | MERIT MEDICAL ANGLETON DIVISION |
| Manufacturer Street | 1111 SOUTH VELASCO |
| Manufacturer City | ANGLETON TX 77515 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77515 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERICARDIOCENTESIS PROCEDURE KIT |
| Generic Name | .038 GUIDE WIRE, 6F PIGTAIL DRAINAGE CATHETER |
| Product Code | DOR |
| Date Received | 2005-10-06 |
| Model Number | NA |
| Catalog Number | PC101 |
| Lot Number | F394727 |
| ID Number | NA |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 704736 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | * SOUTH JORDAN UT 84095 US |
| Baseline Brand Name | PERICARDIOCENTESIS KIT |
| Baseline Generic Name | GUIDEWIRE .038" (ONLY) |
| Baseline Model No | NA |
| Baseline Catalog No | PC101 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-06 |