MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-03-02 for RUSCH TRACHEAL BRONCHIAL Y STENT M00570680 manufactured by Boston Scientific - Marlborough.
[16259818]
It was reported to boston scientific corporation that a dynamic y stent was attempted to be implanted within a tracheal-esophageal fistula around the carina of a patient, on (b)(6), 2011. According to the complainant, during the procedure the physician and anesthesiologist located the patient's vocal cords using a laryngoscope, frietag forceps were then used to place the stent; however a false track was created into the mediastinum. The physician recognized this issue and tried to pull the stent out with alligator forceps; however due to the tight anatomy, and the fistula, the stent was pulled off the retrieval instrument. The stent was unable to be retrieved; therefore the thoracic physician called in an otolaryngologist (ent) to assist in stent removal. A small incision was made in the patient's lower neck and the stent was successfully removed with no problems. Post procedure the patient was sent to the icu with no issues to recover. No further attempts were made to place another stent. Additional follow up received, stated that the patient was discharged from the icu on (b)(6), 2011 and is recovering well. The patient did not develop mediastinitis. The complainant indicated that there was no malfunction or failure of our device.
Patient Sequence No: 1, Text Type: D, B5
[16337025]
The complainant indicated that the device has been 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
| Report Number | 3005099803-2011-00528 |
| MDR Report Key | 2004829 |
| Report Source | 05,07 |
| Date Received | 2011-03-02 |
| Date of Report | 2011-02-07 |
| Date of Event | 2011-02-07 |
| Date Mfgr Received | 2011-02-07 |
| Device Manufacturer Date | 2011-01-04 |
| Date Added to Maude | 2011-03-02 |
| 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 | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH TRACHEAL BRONCHIAL Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2011-03-02 |
| Model Number | M00570680 |
| Lot Number | 0000010501 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| 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; 2. Required No Informationntervention | 2011-03-02 |