MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-29 for TESSYS DISPOSABLE ACCESS KIT TGWS40007 TDAK0020 manufactured by Joimax Gmbh.
[112788801]
The damaged guidewire was returned to the manufacturer, decontaminated, and evaluated. Visual inspection confirmed the reported complaint issue of guidewire fracture. Sem analysis (300x) of the fracture zone revealed the fracture had initiated in a high tension area; however, there were no signs of material inhomogeneity or surface damage in or around the fracture area. Microscopic views revealed the fracture was caused by an overload and not embrittlement or material degradation. The investigation concluded that the there was no indication of a device manufacturing or quality issue and the event was most likely attributed to use error. The guidewire labeling includes the following warning statements: "make sure that the guide wire is not bent during application. A damaged guide wire, e. G. Due to bends, may no longer be used. When inserting the guide rod over the guide wire, avoid jerky forces, such as those potentially occurring when using a hammer, as otherwise shearing forces can lead to the shearing off of the guide wire". Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112788802]
During preparation of endoscopic access to a lumbar disc herniation, a portion of the guidewire sheared off inadvertently. The guidewire fragment was unable to be retrieved and remains implanted in the patient. The procedure was repeated and the surgery was completed successfully. Postoperatively, an x-ray examination was performed and the patient was monitored for signs of discomfort or dislocation. The treatment plan was to leave the remaining guidewire fragment in the patient unless the patient became symptomatic. Additional information has been requested, but no further information was disclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005083075-2018-00001 |
| MDR Report Key | 7651534 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-29 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-24 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2018-06-29 |
| 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 | RAINER STEEGMUELLER |
| Manufacturer Street | AMALIENBADSTRASSE 41 RAUMFABRIK 61 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76227 |
| Manufacturer G1 | ENDOSMART GESELLSCHAFT F |
| Manufacturer Street | LORENZSTR. 6 |
| Manufacturer City | STUTENSEE, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TESSYS DISPOSABLE ACCESS KIT |
| Generic Name | ORTHOPEDIC GUIDEWIRE |
| Product Code | HXI |
| Date Received | 2018-06-29 |
| Returned To Mfg | 2017-05-29 |
| Model Number | TGWS40007 |
| Catalog Number | TDAK0020 |
| Lot Number | 997839 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOIMAX GMBH |
| Manufacturer Address | AMALIENBADSTRASSE 41 RAUMFABRIK 61 KARLSRUHE, 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-29 |