MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for PILLING 522302 manufactured by Teleflex.
[40147172]
Patient Sequence No: 1, Text Type: N, H10
[40147173]
A patient was having a bronchoscopy and conventional mediastinoscopy to obtain biopsies for a lung cancer diagnosis. Per the operative note: the distal trachea, carina, left mainstem, right mainstem, left upper lobe, left lower lobe orifices were all free of any intrinsic intraluminal disease. The bronchoscope was then withdrawn and the patient prepped and draped with the neck extended for a cervical mediastinoscopy. After another general time-out was made, the 2 cm suprasternal notch incision was made for the mediastinoscopy, carried down through the platysma with bovie electrocautery. The strap muscles were separated in the midline and the pretracheal space was then entered under direct vision after gentle blunt digital dissection to establish the pretracheal plane. The cervical mediastinoscope was then inserted under direct vision. Of note, the patient had a rightward angle to his trachea. The mediastinoscope was inserted toward the 4l area and it was noted that the mediastinoscope became lodged in the mid to distal tracheal rings in the left anterolateral area approximately 2 to 3 cm above the carina. Withdrawal of the mediastinoscope revealed an 8 to 10 mm transverse laceration in the anterolateral portion of the trachea at the cartilaginous surface with no evidence of extension inferiorly into the posterior membranous tracheal area. Given the noncircumferential and limited area of the laceration, extensive discussion was had with regard to the optimal management of this after i scrubbed out and inserted the endotracheal tube under direct vision into the right mainstem area to prevent any air leaking. Intraoperative discussion took place with other specialty services/hospitals on how to best approach this in the safest and most effective manner. Given the technically challenging anatomic location and the limited extent of the transversed laceration involving the anterolateral cartilaginous ring surface, it was opted to not pursue immediate aggressive surgical primary repair, such as a complex extended cervical incision versus a partial or full sternotomy or a right or left thoracotomy approach. Simple drainage away from the area of injury with the ample soft tissue coverage available to buffer the area was agreed as the safest most expedient and initial approach. The patient was extubated, monitored in the intensive care unit overnight, and transferred to another hospital for repair by a tracheal specialist. The patient was discharged and is doing well at home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5494765 |
| MDR Report Key | 5494765 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-02-10 |
| Date of Event | 2015-06-10 |
| Report Date | 2016-02-10 |
| Date Reported to FDA | 2016-02-10 |
| Date Reported to Mfgr | 2016-02-10 |
| Date Added to Maude | 2016-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLING |
| Generic Name | MEDIASTINOSCOPE, SURGICAL |
| Product Code | EWY |
| Date Received | 2016-03-11 |
| Model Number | 522302 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-11 |