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 2018-08-07 for UROPASS AS 13/15FR X 46 CM 5/BX 61346BX manufactured by Teleflex Medical Oem.
[116371893]
The device has not been returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To prevent injury to the patient, the instruction manual warns not to advance the device if resistance is felt or the dilator is missing. The placement of the dilator/sheath assembly must also be confirmed via fluoroscopy. The instruction manual also specifies compatible guidewire dimensions, and also contains pre-procedure instructions to inspect the device for damage before use.
Patient Sequence No: 1, Text Type: N, H10
[116371894]
Olympus was informed that at the beginning of a ureteroscopy procedure, the inner dilator tip of the device fell off into the patient while the device was being advanced into the ureter over a guidewire. It was reported that during advancement of the device, resistance was felt, and x-ray confirmed that the fallen off tip was no longer in the ureter. The fallen off device tip was flushed out of the bladder with an ellik device. It was reported that the patient sustained a mild degree of tissue trauma due to the event. The stent associated with the initial procedure was left in place to address the tissue trauma. The procedure was completed with another similar device. It was reported that the patient is currently doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00452 |
| MDR Report Key | 7759962 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-07 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2018-08-07 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UROPASS AS 13/15FR X 46 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-08-07 |
| Model Number | 61346BX |
| Catalog Number | 61346BX |
| Lot Number | 09B1800257 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL OEM |
| Manufacturer Address | 3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |