MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-02 for URETERAL BALLOON DILATOR G14261 010004 manufactured by Cook Inc.
[140946586]
(b)(6). (b)(4). Investigation-evaluation: a review of the complaint history, device history record, instructions for use, manufacturing records, quality control, and specifications of the device was conducted during the investigation. The device was not returned for visual inspection, it had been discarded by the customer at the conclusion of the case, therefore physical evaluation could not performed. A review of the device history record did not reveal any nonconformances associated with lot number 9130571. A review of complaint history records did not reveal any additional complaints associated with lot 9130571. There is no indication that a design process or related failure mode contributed to this event. Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping. Per the quality engineering risk assessment , no further action is necessary as there is no evidence to suggest there is nonconforming product in house or in the field. Based on the information provided, no returned product, and the results of the investigation, a definitive cause could not be established. Cook will continue our monitoring of similar complaints and have notified the appropriate personnel of this event. 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
[140946587]
It is reported during a ureteral dilation procedure to treat stenosis using a cook ureteral balloon dilator, the balloon burst while it was being inflated. It was inflated with 10cc of pressure. This device could not be used to complete the procedure. The physician then used a laser to complete the procedure. The product issue and additional method needed to finish the procedure resulted in an additional 30 minutes of procedure/general anesthesia time for the patient. No adverse events have been reported as a result of the alleged malfunction. Additional information was requested about the patient and event. The customer declined to provide any additional details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00672 |
| MDR Report Key | 8475123 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2019-04-02 |
| 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 | URETERAL BALLOON DILATOR |
| Generic Name | EZN DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2019-04-02 |
| Model Number | G14261 |
| Catalog Number | 010004 |
| Lot Number | 9130571 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-02 |