MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for BIOSENTRY? TRACT SEALANT SYSTEM 768022019S manufactured by Surgical Specialties M?xico, S. De R.l. De C.v..
[122483946]
After a ct guided lung biopsy, a biosentry tract sealant system was being used prevent/reduce risk of pneumothorax. While operating the device, it malfunctioned and subsequently failed to deploy the hydrogel plug. The trocar was removed and hemostasis achieved with manual compression. Post procedure images reflect the absence of a pneumothorax. There was no harm to the patient. Item has been retained by radiology and is pending notification/handoff to surgical specialties field rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7929401 |
| MDR Report Key | 7929401 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-09-18 |
| Report Date | 2018-09-26 |
| Date Reported to FDA | 2018-09-26 |
| Date Reported to Mfgr | 2018-10-03 |
| Date Added to Maude | 2018-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSENTRY? TRACT SEALANT SYSTEM |
| Generic Name | ABSORBABLE LUNG BIOPSY PLUG |
| Product Code | OMT |
| Date Received | 2018-10-03 |
| Model Number | 768022019S |
| Catalog Number | 768022019S |
| Lot Number | AABX484 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES M?XICO, S. DE R.L. DE C.V. |
| Manufacturer Address | 247 STATION DRIVE, NE1 WESTWOOD MA 02090 US 02090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-03 |