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 2019-04-25 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS G56436 FUS-120045-P manufactured by Cook Inc.
[144152237]
Concomitant products: t? Rumo 0. 35 stiff hydrophilic guide. 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
[144152238]
It was reported during a flexible ureteroscopy procedure using a cook access tube for flexible ureteroscope (ch12 / 14, length 45 cm), and a hydrophilic guide t? Rumo 0. 35 safety already in place, after passing physiological saline on the guide as the access duct as usual the user then placed the guide in the mandrel of the access duct and made it out through its lateral orifice as expected. Rise of the sheath was observed under fluoroscopy. The guide mismatched the mandrel (without having unclipped) and there was risk of perforation in the ureter or in the bladder. The doctor used the standard flexor-p access sheath with the standard technique. The procedure was completed using 2 terumo brand stiff hydrophilic guides mounted one after the other in the patient to then inserted the flexor-p ureteral access sheath through its main axis (and no longer through its parallel access). It was reported that no adverse consequence to the patient has occurred. This report is related to mfr. Reports 1820334-2019-00775 and 1820334-2019-00774. This is third event in which a similar event was experienced by the second physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00904 |
| MDR Report Key | 8552209 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-25 |
| Date of Report | 2019-05-16 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2019-01-07 |
| Date Added to Maude | 2019-04-25 |
| 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 | 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 | 2019-04-25 |
| Model Number | G56436 |
| Catalog Number | FUS-120045-P |
| Lot Number | 9425050 |
| 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 | 2019-04-25 |