MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-03-05 for ENTERYX PROCEDURE KIT M00572600 7260 manufactured by Boston Scientific Corporation- Marlborough.
[1060324]
Note: the event occurred in 2004; the actual event date is unknown. It was reported to boston scientific corporation on october 16, 2006 that an enteryx procedure kit was implanted (male patient; age and weight are unknown). According to the complainant, the patient had two separate procedures of enteryx implants and both procedures were "successful". Two years later, the "patient has developed esophageal varicies (physician thought grade i) although patient has no liver disease. The physician's impressions were that there might have been an injection of enteryx in the submucosal veins. Seems to be some bulking at the distal esophagus. Additional test were completed - eus (2004) and ct scan (same month). Impressions were that the enteryx material had tracked 13 cm 'up' the esophagus. The physician mentioned he was going to write this scenario up and report it. "
Patient Sequence No: 1, Text Type: D, B5
[8224962]
Other (esophageal varicies). The lot number is unknown; therefore, the manufacture date cannot be determined. The device remains implanted in the patient; therefore, a device evaluation cannot be performed. Note: this product was removed from the global market in september 2005. Boston scientific corporation no longer produces the reported product. Other: product unavailable for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02650 |
| MDR Report Key | 1333591 |
| Report Source | 05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2006-10-16 |
| Date Mfgr Received | 2006-10-16 |
| Date Added to Maude | 2009-03-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0040-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERYX PROCEDURE KIT |
| Generic Name | CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES |
| Product Code | LMN |
| Date Received | 2009-03-05 |
| Model Number | M00572600 |
| Catalog Number | 7260 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-05 |