| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS | BOSTON SCIENTIFIC - MARLBOROUGH | PIF | UNK518 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-23 | 0 | 1. H |
Patient 1
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE INITIAL PLACEMENT PEG KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2018, IT WAS FOUND THAT THE PATIENT HAD GASTRIC ULCER THROUGH GASTROSCOPY. THE PEG TUBE WAS REMOVED AS IT DID NOT HELP THE HEALING PROCESS OF THE ULCER. REPORTEDLY, THE GASTRIC ULCER WAS LOCATED NEAR TO THE PROXIMITY OF THE PEG TUBE AND IT WAS NOT PRESENT BEFORE THE PEG TUBE WAS IMPLANTED. REPLACEMENT OF PEG TUBE WILL BE RE-EVALUATED ONCE THE SITUATION BECOMES NORMAL. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.