MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-18 for DYNAMIC Y STENT M00570690 manufactured by Boston Scientific - Marlborough.
[3094999]
It was reported to boston scientific corporation that a dynamic y stent was used during a bronchoscopy procedure performed on (b)(6) 2012. According to the complainant, the patient had a tracheal compression due to malignant mediastinum mass. Prior to the procedure the patient's condition was reported to be "bad". The patient's anatomy was reported to be tortuous; the distal portion and right stem was very occluded/compressed. During the procedure, the physician made four attempts to implant the stent within the patient's bronchus using frieteg forceps. After the fourth attempt the physician thought the stent was placed properly, a laryngoscope was used to verify stent placement and found that the stent was not placed correctly. The stent was not in the bronchus, but in the esophagus. The physician tried to remove the stent but experienced difficulty. During the physician's attempt to remove the stent, the patient experienced respiratory failure due to the airway becoming blocked. The patient was resuscitated and a gastroenterologist removed the stent from the esophagus. The physician opted to abort the procedure due to the patients condition and inability to place the dynamic y stent. The patient's condition was reported to be stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
[10233166]
(b)(4) - the reported issue of stent positioning problem. (b)(4) - the reported issue of difficulty removing stent. 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 | 3005099803-2012-04836 |
| MDR Report Key | 2796497 |
| Report Source | 05,07 |
| Date Received | 2012-10-18 |
| Date of Report | 2012-09-25 |
| Date of Event | 2012-09-25 |
| Date Mfgr Received | 2012-09-25 |
| Device Manufacturer Date | 2012-07-05 |
| Date Added to Maude | 2012-10-18 |
| 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 | 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 | DYNAMIC Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2012-10-18 |
| Model Number | M00570690 |
| Lot Number | 0000012251 |
| Device Expiration Date | 2017-05-31 |
| Operator | PHYSICIAN |
| 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. Required No Informationntervention | 2012-10-18 |