MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-08-14 for POLYFLEX SINGLE-USE ESOPHAGEAL STENT SYSTEM 1430 manufactured by Rusch Gmbh Germany/ Teleflex Medical.
[497066]
The complainant has reported that a patient (age and gender unknown) with esophageal malignancy/esophageal carcinoma underwent a therapeutic polyflex single-use esophageal stent system placement. A soft gastroscope was reported used and during the procedure it was noted that the stent perforated the distal esophagus. The procedure was then shorted due to the event, the stent was removed and the patient uderwent an open esophageal perforation repair, sans tracheostomy. The patient condition is reported good and recovering well, yet with a poor prognosis due to the esophageal malignancy.
Patient Sequence No: 1, Text Type: D, B5
[7835428]
Information supplied in section f was completed by the manufacturer based on information obtained from the user facility. Any information not included in this section or any other section was na at the time of submission of this medwatch report to the fda. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine if the device met specification. Should further relevant details become available: a supplemental medwatch report will be filed under the appropriate sequence number. We are unable to determine the relationship between this device and the cause for this event at this time. Our directions for use outline appropriate placement, access and maintenance procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000146-2006-00006 |
| MDR Report Key | 753741 |
| Report Source | 05,06,07 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-08-14 |
| Date of Event | 2006-08-14 |
| Date Mfgr Received | 2006-08-14 |
| Date Added to Maude | 2006-08-25 |
| 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 | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | RUSCH GMBH GERMANY/ TELEFLEX MEDICAL |
| Manufacturer Street | 2345 WAUKEGAN RD. |
| Manufacturer City | BANNOCKBURN IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX SINGLE-USE ESOPHAGEAL STENT SYSTEM |
| Generic Name | ESOPHAGEAL STENT |
| Product Code | EJW |
| Date Received | 2006-08-14 |
| Model Number | NA |
| Catalog Number | 1430 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 741556 |
| Manufacturer | RUSCH GMBH GERMANY/ TELEFLEX MEDICAL |
| Manufacturer Address | 2345 WAUKEGAN RD. BANNOCKBURN IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-14 |