MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2009-04-17 for DYNAMIC Y STENT M00570690 7069 manufactured by Boston Scientific Corporation.
[21785287]
It was reported to boston scientific corp. In 2009 that a dynamic y stent was used during a procedure (male pt). According to the complainant, the pt was having the stent removed due to an abscess that developed as a result of the stent rubbing on the bronchus when the pt would cough. The physician went down the pt's trachea with freitag forceps to remove the stent. On multiple attempts to remove the stent, the freitag forceps became lodged between the trachea and the stent. Once they got the forceps inside the stent of the right and left main stem bronchi and closed down the forceps, the proximal trachea would prevent removal of the stent because of tracheal another country. The physician made 3 attempts to remove the stent with freitag forceps and all three attempts failed. Afterwards, the physician went down the pt's trachea with rat tooth forceps and was able to grab the proximal end of the stent and remove it from the pt. Another stent was not placed at that time. The pt was kept overnight for observation following the procedure. The pt was discharged the following day and it doing well.
Patient Sequence No: 1, Text Type: D, B5
[21827614]
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 will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. The complainant was unable to provide the suspect device lot number; therefore, the device manufacture and expiration dates are unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-01941 |
| MDR Report Key | 1367579 |
| Report Source | 04,05 |
| Date Received | 2009-04-17 |
| Date of Report | 2009-03-26 |
| Date of Event | 2009-03-26 |
| Date Mfgr Received | 2009-03-26 |
| Date Added to Maude | 2009-04-27 |
| 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 | MEDICAL SCIENTIFIC, INC. |
| Manufacturer Street | 125 JOHN HANCOCK RD. |
| Manufacturer City | TAUNTON MA 02780 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Product Code | NYT |
| Date Received | 2009-04-17 |
| 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. Hospitalization; 2. Required No Informationntervention | 2009-04-17 |