MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-05 for HEARTMATE APICAL CORING KNIFE 1050 manufactured by Thoratec Corp..
[17369230]
It was reported by the hospital lvad coordinator that during the implant procedure, while coring of the ventricular apex, the coring knife was found to be dull and would not core through the apex. The surgeon then decided to use scissors to cut the core of the ventricular apex without injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[17662554]
The evaluation of the coring knife revealed damage to the cutting surface that may have affected the performance of the coring knife. The evaluation of the coring knife revealed two chips on the cutting edge that appeared to be mechanically induced; however, the analysis could not clearly determine the exact mechanism that contributed to the observed surface damage. No further information is available. The manufacturer is closing its file on this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2009-00049 |
| MDR Report Key | 1334591 |
| Report Source | 05,06 |
| Date Received | 2009-03-05 |
| Date of Report | 2009-02-03 |
| Date of Event | 2009-02-03 |
| Date Facility Aware | 2009-02-03 |
| Report Date | 2009-02-03 |
| Date Reported to Mfgr | 2009-02-03 |
| Date Mfgr Received | 2009-02-03 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2009-10-20 |
| 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 | 3 |
| Manufacturer Contact | ROBERT FRYC |
| Manufacturer Street | 23 FOURTH AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812720139 |
| Manufacturer G1 | THORATEC CORP. |
| Manufacturer Street | 6035 STONERIDGE DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE APICAL CORING KNIFE |
| Generic Name | APICAL CORING KNIFE |
| Product Code | EMF |
| Date Received | 2009-03-05 |
| Returned To Mfg | 2009-02-10 |
| Model Number | 1050 |
| Catalog Number | 1050 |
| Lot Number | 74363 |
| Device Expiration Date | 2011-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-03-05 |