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 2018-05-23 for ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT UNK518 manufactured by Boston Scientific - Marlborough.
[109044283]
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 Sequence No: 1, Text Type: N, H10
[109044284]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01672 |
| MDR Report Key | 7537861 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-05-03 |
| Date Added to Maude | 2018-05-23 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2018-05-23 |
| Model Number | UNK518 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-23 |