MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-09-26 for UROPASS AS 10/12FR X 46 CM 5/BX 61046BX manufactured by Teleflex Medical Oem.
[121856966]
The access sheaths will not be returned to olympus for evaluation as the user facility discarded them following the procedure. The cause of the reported event cannot be confirmed. However, based on the reported information, the operator? S technique cannot be ruled out as a contributory factor of the reported event. The reported event is listed as a potential complication that can occur during operation. The instruction manual (section 3. 0) states,? Patients or their representatives should be informed of the possible complications associated with the use of this product. (b)(4) requests that physicians notify the company of complications that may occur with the use of this device. Complications may include but are not limited to mucosal irritation, inflammation and perforation of the urethra, bladder, or ureter.? In addition, do not apply excessive force to the product or use it excessively. It is likely to injure or cause perforation in the urinary tract of the patient. The instruction manual states,? Advance the dilator/sheath assembly over the guidewire to the desired location. If resistance is encountered, stop! Do not advance against resistance. Damage to the anatomy could result.?
Patient Sequence No: 1, Text Type: N, H10
[121856967]
Olympus was informed that on (b)(6) 2018 an olympus urf-v2 was inserted into the renal pelvic using a non-olympus rigid cystoscope, non-olympus guide wire, and an olympus access sheath, 61138bx. The physician determined that an access sheath of a thinner diameter was required, the physician changed to a 61046bx and the renal pelvic biopsy procedure was completed without issue. Following the renal pelvic biopsy procedure, a non-olympus stent was placed in the patient? S ureter using a non-olympus rigid cystoscope and guide wire. After some time attempting to pass the guide wire through the ureteral opening, another doctor passed the guide wire and placed the ureteral stent. No olympus access sheath was used for the procedure of indwelling the stent. There were no malfunctions noted on the concerned equipment. On (b)(6) 2018, the stent was removed from the patient. On (b)(6) 2018, the patient visited the outpatient clinic due to a fever. During the visit they found ureteral damage as a urinary cyst had formed. On (b)(6) 2018, the stent was placed back in the ureter. On (b)(6) 2018, the urinary cyst was punctured and drained under a ct guide. On (b)(6) 2018 the stent was removed from the patient and the patient was discharged from the hospital. Two of 2 devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00577 |
| MDR Report Key | 7912636 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-26 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-06-11 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-09-26 |
| 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 | 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 10/12FR X 46 CM 5/BX |
| Generic Name | UROPASS ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-09-26 |
| Model Number | 61046BX |
| Catalog Number | 61046BX |
| Lot Number | 09D1700084 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-09-26 |