MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-03-05 for DYNAMIC Y STENT M00570670 manufactured by Boston Scientific - Marlborough.
[20955342]
It was reported to boston scientific corporation that a dynamic y stent was used during a rigid bronchoscopy with tracheal stent placement procedure on (b)(6), 2012. According to the complainant, the indication for the stent placement was treatment for a te fistula. The patient was not noted to have tortuous anatomy. After positioning the stent at the carina, the pusher on the freitag forceps punctured the stent creating a hole. The stent was removed from the patient. The procedure was completed with another dynamic y stent using the freitag forceps. There were no patient complications as a result of this event. The patient condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[21211654]
A visual examination of the returned device noted a hole on the device. The stent length was measured to be 85mm. No other irregularity could be observed. The investigation confirmed that the condition of the returned device was consistent with the complaint incident that the stent was damaged. A review of the manufacturing documentation showed no manufacturing errors during any step of the production process. A review of the complaint database revealed that no similar complaints exist for the specified batch. The investigation concluded that the complaint was associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited. The most probable root cause classification is operational context.
Patient Sequence No: 1, Text Type: N, H10
[22045158]
It was reported to boston scientific corporation that a dynamic y stent was used during a rigid bronchoscopy with tracheal stent placement procedure on (b)(6) 2012. According to the complainant, the indication for the stent placement was treatment for a te fistula. The patient was not noted to have tortuous anatomy. After positioning the stent at the carina, the pusher on the freitag forceps punctured the stent creating a hole. The stent was removed from the patient. The procedure was completed with another dynamic y stent using the freitag forceps. There were no patient complications as a result of this event. The patient condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[22132803]
(b)(4) for the reported event of hole present in stent. The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2012-00762 |
| MDR Report Key | 2478337 |
| Report Source | 05,07 |
| Date Received | 2012-03-05 |
| Date of Report | 2012-02-10 |
| Date of Event | 2012-02-08 |
| Date Mfgr Received | 2012-05-10 |
| Device Manufacturer Date | 2011-02-16 |
| Date Added to Maude | 2012-03-05 |
| 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 | 2012-03-05 |
| Returned To Mfg | 2012-03-07 |
| Model Number | M00570670 |
| Lot Number | 0000011041 |
| Device Expiration Date | 2015-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-03-05 |