MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other report with the FDA on 2019-05-31 for N/A manufactured by Cook Inc.
[146701690]
Suspect medical device: specific product information currently unavailable. Initial reporter also sent report to fda: unknown. Pma/510(k) #: preamendment. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[146701691]
The below description of tension hemothorax following use of a cook kellett needle was taken from the following journal article: sundar, gaurav, pradesh kumar. "tension hemothorax: a rare complication and how to avoid it. " j clin interv radiol 1 (2017): 190-191. As stated in the article, "a (b)(6) man was admitted with shortness of breath and a productive cough and diagnosed with severe community-acquired pneumonia. A computed tomography (ct) of the chest showed that the patient had a complex right-sided pleural effusion suspicious of an empyema. As he was not responding to antibiotics, he was referred for an ultrasound guided drainage of the effusion. The procedure was performed via a posterior approach using the seldinger technique. On initial placement of a kellett needle (cook) immediately superior to the rib border under ultrasound guidance, frank blood was aspirated from the pleural cavity. The posterior approach was abandoned and the kellett needle removed. The procedure was abandoned, and a ct of the chest was ordered. This demonstrated no evidence of active hemorrhage, and therefore the patient was returned to the ward for close observation. Two hours later, the patient became hemodynamically unstable with signs of cardiopulmonary compromise. A bedside chest x-ray done showed a large volume right-sided effusion resulting in mediastinal shift. An emergency thoracostomy was performed at the bedside to treat the imminent cardiorespiratory failure. A large quantity of blood was evacuated, but the patient remained tachycardic and hypotensive. An urgent ct showed active contrast extravasation from an intercostal artery at the site of the needle insertion. The patient was subsequently transferred to the interventional radiology (ir) suite where an angiogram showed active bleeding from the right seventh intercostal artery. This was successfully embolized using a several small micro coils. Post embolization he was managed in the critical care unit. There was difficulty weaning him off the ventilator and he required a tracheostomy. " regarding the patient's outcome, it was further stated, "after a protracted stay in the critical care unit and subsequent surgical pleural decortication, he gradually improved and was discharged in a stable condition. A ct done 6 months later showed a right-sided fibrothorax and the patient remains symptomatically well. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01338 |
| MDR Report Key | 8659850 |
| Report Source | FOREIGN,LITERATURE,OTHER |
| Date Received | 2019-05-31 |
| Date of Report | 2019-08-13 |
| Date Mfgr Received | 2019-08-07 |
| Date Added to Maude | 2019-05-31 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GCB NEEDLE, CATHETER |
| Product Code | GCB |
| Date Received | 2019-05-31 |
| Model Number | N/A |
| 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 | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-05-31 |