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 2019-04-04 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120045-P manufactured by Cook Inc.
[141489553]
Concomitant medical products: hydrophilic guide t? Rumo 0. 35. 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
[141489554]
It was initially reported a problem device flexor-p reference fus-xxxxxx-p. No patient damage to date, but a risk of tissue perforation due to the hydrophilic guide that separates from the ureteral access sheath flexor-p during its placement in the patient. Additional information was provided on (b)(6) 2019: i am reporting a recent incident (which has happened to me once in the past) when using one of your cook access tubes for flexible ureteroscope (ch12 / 14, length 45 cm). On (b)(6) 2019, while performing a nephrolithotomy with left ureteroscopy, a hydrophilic guide t? Rumo 0. 35 safety was already in place in the left ureter. I passed physiological saline on the guide as the access duct as usual and i placed the guide in the mandrel of the access duct and made it out through its lateral orifice as expected. I realized the rise of the sheath under fluoroscopy and saw that at the level of the bladder neck about the guide mismatched the mandrel (without having unclipped) so that i risked to climb in the ureter or in bladder wall without guide which is dangerous. Thanks to the fluoroscopy, i was able to realize it and remove the access duct to replace it but this time on a second guide put in all the length of the chuck by its central light, this time without incident. Additional details about the patient and event have been requested. At the time of this report, this is all of the information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00775 |
| MDR Report Key | 8484758 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-04 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-04-04 |
| 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 |
| Brand Name | FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | EZN DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2019-04-04 |
| Catalog Number | FUS-120045-P |
| 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 | 2019-04-04 |