MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-28 for 0.035" STIFF ANGTIP 43BX manufactured by Lake Region Manufacturing.
[146278199]
The device was not returned to the service center for evaluation. The cause of the reported event cannot be determined at this time; however, the instruction manual warns users "inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc. "
Patient Sequence No: 1, Text Type: N, H10
[146278200]
The service center was informed that at the beginning of a therapeutic percutaneous nephrolithotomy (pcnl) procedure, the tip of the guidewire broke off and fell into the patient. The procedure was completed with a new access site placed. The patient required a prolonged stay and additional procedure to locate and attempt retrieval of the tip. No significant bleeding occurred. The procedure was prolonged by approximately 1 hour. The device fragment was unable to be retrieved. No further harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00886 |
| MDR Report Key | 8647335 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-28 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-09-26 |
| Date Added to Maude | 2019-05-28 |
| 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" STIFF ANGTIP |
| Generic Name | 0.035" STIFF ANGTIP |
| Product Code | EYA |
| Date Received | 2019-05-28 |
| Model Number | 43BX |
| Lot Number | 11021340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MANUFACTURING |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-28 |