MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-20 for MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET C-TCCS-350 manufactured by Cook Inc.
[117689647]
(b)(6). Preliminary investigation -evaluation: the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "... Warnings:... Consideration should be given to the following medical and anatomic conditions: distorted anatomy. Subcutaneous abscess. Hematoma. Post-operative scarring/radiation. Coagulopathies or systemic thrombolytic therapy... Instructions for use... Advance the soft, flexible end of the wire guide through the catheter or needle and into the airway several centimeters. Remove the catheter or needle, leaving the wire guide in place. Advance the handled dilator, tapered end first, into the connector end of the airway catheter until the handle stops against the connector. Note: this step may be performed prior to beginning the procedure. Use of lubrication on the surface of the dilator may enhance fit and placement of the airway catheter. Advance the airway catheter/dilator assembly over the wire guide until the proximal stiff end of the wire guide is completed through and visible at the handle end of the dilator. It is important to continually visualize the proximal end of the wire guide during the airway insertion procedure to prevent its inadvertent loss into the trachea. Maintaining wire guide position, continue to advance the airway catheter/dilator assembly over the wire guide with a reciprocation motion completely into the trachea. Take care not to advance the tip pf the dilator beyond the tip of the wire guide within the trachea... How supplied... ... Upon removal from package, inspect the product to ensure no damage has occurred. " based on the information provided, no product returned and the results of the investigation, a definitive root cause could not be determined. 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
[117689648]
A letter was received on (b)(6) 2018 from (b)(6) hospital (b)(6) informing the manufacturer of an incident that occurred on (b)(6) 2018. It was reported a patient underwent a cricothyrotomy procedure performed by a doctor from (b)(6) team in an emergency vehicle. The patient was in cardiopulmonary arrest due to a quincke edema for 15-minutes prior to the initiation of procedure. The patient passed not because of a failed procedure but because vitals were compromised from cardiopulmonary arrest. A (b)(6) emergency cricothyrotomy catheter set was the. Device utilized in the cricothyrotomy. As reported, the guide for mounting the cannula broke when removing the dilator. The cricothyroidotomy was unable to be performed relate to edema. When the edema regressed, the patient was intubated by oral trachea route. Additional information has been requested including if an autopsy report is available, additional sequence of event details, the length of time before oral tracheal intubation was achieved, and medications and other devices used during this event. However, the reporter stated that the patient death was not linked with use of the device. Therefore, they would not communicate any more data than was previously reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02219 |
| MDR Report Key | 7799908 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-20 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2017-06-17 |
| Date Added to Maude | 2018-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Brand Name | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
| Generic Name | BWC NEEDLE, EMERGENCY AIRWAY |
| Product Code | BWC |
| Date Received | 2018-08-20 |
| Model Number | NA |
| Catalog Number | C-TCCS-350 |
| Lot Number | 7999072 |
| 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. Death; 2. Other | 2018-08-20 |