MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-13 for PRUITT F3 CAROTID SHUNT 2012-10 manufactured by Lemaitre Vascular, Inc..
[185004309]
We have received the complaint device for evaluation. However, we observed the side of the foil pouch that the customer reported to have a cut to be completely ripped. We have observed the reported incident in the picture that the customer previously provided to us showing a small slit on the top right section of the packaging foil pouch. We have also received the outer box that was used to package this foil pouch. We observed one side of this box to be damaged. The hole that we observed in the foil pouch corresponds to the damage that was observed on the outer box of the f3 shunt. Based on our evaluation, it is likely the foil pouch was damaged during shipping the device to the user facility. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. Further, we have not received any other complaints of a similar nature for devices from this lot. Therefore, we believe that it was an isolated incident. The defect was detected by the surgeon during pre-use check. Device was not used for the procedure.
Patient Sequence No: 1, Text Type: N, H10
[185004310]
During pre-use check, user found a small cut on the outer packaging of the f3 carotid shunt. Device was not used for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00017 |
| MDR Report Key | 9708682 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-02-15 |
| Date Added to Maude | 2020-02-13 |
| 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 | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 2212266152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRUITT F3 CAROTID SHUNT |
| Generic Name | CAROTID SHUNT |
| Product Code | MJN |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 2012-10 |
| Catalog Number | 2012-10 |
| Lot Number | PFT3560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |