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 2020-01-24 for PRUITT F3-S POLYURETHANE CAROTID SHUNT 2014-10 2012-10 manufactured by Lemaitre Vascular, Inc..
[181541100]
We have received the complaint device for evaluation. When the common carotid balloon was inflated with recommended volume of 1. 5 ml of saline using a syringe, the balloon inflated properly. When we attempted to deflate the balloon using the same syringe, it failed to deflate. We observed that the balloon walls had covered the inflation holes preventing the saline from entering into the inflation lumen. As a result, the balloon could not deflate. 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. Our manufacturing team does conduct 100% inspection on each device and tests them for balloon functionality. Each balloon is inspected to ensure they inflate and deflate properly. It is also possible that during manufacturing, the balloon was poorly assembled which could have led to this issue. Multiple inflation or over-inflation of the common carotid balloon at the hospital could have also contributed to this issue since we observed the balloon to have been overly stretched during our device evaluation. We have currently implemented a corrective and preventive action (capa) which includes a process change along with retraining of operators that we believe will assist the balloons to inflate and deflate uniformly along its entire circumference preventing further occurrences of similar issues. Device was not used in a patient. Procedure was completed using another shunt that they had in stock.
Patient Sequence No: 1, Text Type: N, H10
[181541101]
At the beginning of a carotid endarterectomy (cea) procedure, during pre-use check, surgeon inflated the occlusion balloons of the lemaitre f3-s carotid shunt to test balloon functionality. He observed both balloons to have inflated properly. However, during deflation, he observed that the common carotid balloon failed to deflate. Device was not used for the procedure. Surgeon then replaced this device with another f3-s carotid shunt to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00011 |
| MDR Report Key | 9628985 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2018-11-14 |
| Date Added to Maude | 2020-01-24 |
| 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 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRUITT F3-S POLYURETHANE CAROTID SHUNT |
| Generic Name | CAROTID SHUNT |
| Product Code | MJN |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 2014-10 |
| Catalog Number | 2012-10 |
| Lot Number | PFP1071 |
| 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 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |