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 2020-03-04 for PRUITT F3 CAROTID SHUNT 2012-10 manufactured by Lemaitre Vascular, Inc..
[185574036]
We have received the complaint device for evaluation and we have confirmed the reported incident. We observed a leakage at the blue stopcock joint when we attempted to inject liquid into the common carotid balloon. As a result, the common carotid balloon failed to inflate. Upon further inspection of the joint, we observed an inadequate amount of glue at the stopcock joint. Internal carotid balloon inflated and deflated properly. The root cause of the issue was determined to be an operator error- not enough glue was applied on the stopcock joint during the assembly process. 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. We currently have a corrective and preventive action (capa) open to address this issue and prevent them from reoccurring. The issue was detected during pre-use check. Device was not used for the procedure.
Patient Sequence No: 1, Text Type: N, H10
[185574037]
During pre-use check, when the user attempted to inflate the common carotid balloon with saline, the balloon failed to inflate. The malfunction was detected during pre-use check. Surgeon used another f3 shunt for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00025 |
| MDR Report Key | 9787743 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2018-10-31 |
| Date Added to Maude | 2020-03-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| 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 | 2020-03-04 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 2012-10 |
| Catalog Number | 2012-10 |
| Lot Number | PFT3494 |
| 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 | 2020-03-04 |