MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-24 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.
[146223546]
The device was not returned to the service center for evaluation. The cause of the event cannot be determined at this time. However, this type of guidewire damage is most likely related to the operator's technique. The instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire. ? Inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc. Carefully and slowly withdraw the guidewire from the patient to avoid any damage.?
Patient Sequence No: 1, Text Type: N, H10
[146223547]
The service center was informed that the surgeon was performing a right flexible ureteroscopy with laser lithotripsy, stone manipulation/extraction and stent placement procedure at the right ureteropelvic junction (upj), when the guidewire tip broke off in the patient? S kidney. It was reported that the wire broke, while removing stone fragments, under fluoro visualization. The patient required an increased anesthesia time for the 1 1/2 hour prolongation for the removal and sustained some additional ureteral trauma that required the stent be left in for a longer period of time post-op. There was no unexpected bleeding reported. The procedure was completed with the removal of the device fragment. The patient did not require additional procedures and as of the last communication was doing fine with the stent in situ. In addition, the user facility reported that the device was inspected visually before inserted as it always is to insure that we inserted the flexible end first. Any noticeable issue should have been seen at this point and none were noted. There was no lithotripsy system directly fired upon the device. It is unknown if the thumb advance introducer was used. The guidewire did not come in contact with any metal tip of the instruments used during the procedure. There was no excessive force applied to withdraw or introduce the guidewire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00884 |
| MDR Report Key | 8642787 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-24 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-08-19 |
| Date Added to Maude | 2019-05-24 |
| 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 | 0.035" HYBRID WIRE, BOX OF 5 |
| Generic Name | UROLOGICAL HYBRID WIRE |
| Product Code | EYA |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-06-03 |
| Model Number | GWH3505R |
| Lot Number | 91804490 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | ERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 72581 GM 72581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-24 |