MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-07-18 for THAL-QUICK CHEST TUBE SET C-TQTS-2000 manufactured by Cook, Inc..
[3624954]
Original information provided (b)(6) 2013. Aspiration of lung vein, incident happened in (b)(6) already but customer never got back to sales rep. Information provided (b)(6) 2013: the above described device was being utilized in an (b)(6) female pt. The pt had a pre-existing condition of pneumonia and pleuracentesis on the right side. The physician was conducting a thoracentesis on the right side and there was an aspiration of lung vein, the incident happened in (b)(6), but customer did not notify sales rep. The pt was sitting in an upright position, puncture occurred with ultrasound. It was indicated that the pt had multiple reanimations and transfusions and intraoperative suture of the vein "pulunmnate". Surgical revision had to be done as a result of this occurrence. Pleura drainage placement (b)(6) 2013, 8:45am. First, aspiration of yellowish serous fluid and placement of the seldinger wire of the thal quick thorax drainage set. Then dilation to 22f without complication. Yellowish serous fluid seeps through the puncture hole. The drainage catheter is placed a few centimeters in through the dilated hole using the stylet and then the stylet slightly pulled back. At first, the yellowish fluid can be seen in the drainage tube but when advancing further, suddenly dark red blood can be seen. Additional information received (b)(6) 2013: yes, it is was the "punktion" of the vein. No device remains in the body.
Patient Sequence No: 1, Text Type: D, B5
[10894785]
Lot and expiration: lot provided (4205852) was manufactured after the event occurred. Although requested, no additional information has been provided. Age of device is uncertain as lot number provided was manufactured after the event occurred. (b)(4). Manufacture date: this information reflects the lot number provided by the customer. Event eval: per information supplied by the customer, the product will not be returned. The catheter is inspected according to confirm the correct type and size tubing, overall length, and presence of black markers. Additionally, quality control (qc) confirms that the radiopaque stripe is uniform. The product is shipped with instructions for use (ifu), which provides insertion instructions, warnings and precautions. The ifu contains the following warning, "over insertion of the needle and/or dilators may result in serious harm to the pt. " additionally, the ifu contains the following notes, "due to anatomical variations in chest wall thickness, insertion depth of introducer needle, wire guide, and dilators will vary from pt to pt," and, "the distal end of the chest tube inserter should not be advanced beyond the distal end of the wire guide. " per information supplied by the customer, "first aspiration of yellowish serous fluid and placement of the seldinger wire of the thal quick thorax drainage set. Then dilation to 22f without complication. Yellowish serous fluid seeps through the puncture hole. The drainage catheter is placed a few centimeters in through the dilated hole using the stylet and then the stylet slightly pulled back. At first, the yellowish fluid can be seen in the drainage tube but when advancing further, suddenly dark red blood can be seen. It is likely that this failure was due to placement technique or abnormal pt anatomy, which led to over insertion of the device as the description of the event suggests that a vein was punctured during catheter placement. Surgical revision was completed. We will continue to monitor for similar complaints and have notified the appropriate personnel. Per the conclusion of quality engineering risk assessment (qera), no risk mitigating action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00294 |
| MDR Report Key | 3245714 |
| Report Source | 01,08 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-17 |
| Date of Event | 2013-03-12 |
| Date Facility Aware | 2013-03-12 |
| Report Date | 2013-06-17 |
| Date Mfgr Received | 2013-06-18 |
| Device Manufacturer Date | 2013-04-24 |
| Date Added to Maude | 2013-07-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RONDA BARNES |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THAL-QUICK CHEST TUBE SET |
| Generic Name | DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Product Code | PAD |
| Date Received | 2013-07-18 |
| Model Number | NA |
| Catalog Number | C-TQTS-2000 |
| Lot Number | 4205852 |
| ID Number | NA |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-18 |