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 2018-12-03 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120035-P manufactured by Cook Inc.
[129030955]
Concomitant medical products: omnipak contrast medium, terumo guide wire, and rigid cystoscope with foreign body forceps. (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
[129030956]
It was reported, during a flexible ureteroscopy in the kidney, the flexor parallel ureteral access sheath and dilator was inserted into the patient and passed through the wall and perforated the renal vein. After inserting the device into the patient, opacification was performed to visualize the positioning of the product and found that the contrast fluid was not directed to the kidney but to the renal vein. According to the physician, he did not force the product and did not feel resistance. The patient's anatomy was described as being a normal and "compliant ureter. " a double j catheter was placed and blood count was monitored every hour for six hours. The intervention of the stone could not be carried out and will require a second procedure to remove the stone after healing. The patient was reported to be in "good health" and the patient's current status is listed as "back to normal," no additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03436 |
| MDR Report Key | 8124207 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-03 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2018-12-03 |
| 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 | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-12-03 |
| Returned To Mfg | 2019-02-06 |
| Catalog Number | FUS-120035-P |
| Lot Number | 9124878 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2018-12-03 |