MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-10 for DYNAMIC Y STENT M00570690 7069 manufactured by Boston Scientific Corporation.
[1038119]
It was reported to boston scientific corp that a dynamic y stent was used during a stent placement procedure. According to the complainant, during stent placement the bifurcated side of the stent kept going down the right side of the bronchus instead of bifurcating at the bronchus. Each additional attempt at stent placement resulted in the stent traveling down the right side of the bronchus versus the bifurcation. Following each failed attempt, the stent was dragged back into the middle trachea by forceps. As the forceps were being pulled out, the pt's airway became blocked. Due to the multiple attempts and the blocked airway, bag-mask ventilation was required multiple times during the procedure. On one occasion, they were unable to get a co2 reading. As well, the slide bar on the forceps kept getting hung up on the epiglottis and soft tissue causing edema of the vocal chords and epiglottis. During the seventh attempt to place the stent, it was difficult to find the bronchial anatomy due to soft tissue swelling resulting in inadvertent placement of the stent in the pt's esophagus. Upon the eighth attempt to place the stent, the stent was placed down to the carina but it would not open. A flexible bronchoscope was utilized. The pt and stent were intubated and the bifurcated portion of the stent was steered into the right airway. They then utilized an endotracheal tube to push the stent distally to feed it properly at the carina, and were able to open the stent into the correct position. The procedure was prolonged and lasted for three hours. The pt is stable and breathing on her own.
Patient Sequence No: 1, Text Type: D, B5
[8150831]
The complainant was unable to provide the suspect device lot number; therefore, the device expiration date and manufacture date are unknown. The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant info from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-00470 |
| MDR Report Key | 1311580 |
| Report Source | 05,07 |
| Date Received | 2009-02-10 |
| Date of Report | 2009-01-13 |
| Date of Event | 2009-01-13 |
| Date Mfgr Received | 2009-01-13 |
| Date Added to Maude | 2009-02-18 |
| 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 | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | WILLY RUSCH GMBH |
| Manufacturer Street | WILLY RUSCH STRAUSSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Product Code | NYT |
| Date Received | 2009-02-10 |
| Model Number | M00570690 |
| Catalog Number | 7069 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-02-10 |