MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-07 for ZIPWIRE HYDROPHILIC GUIDEWIRE M006630222B1 630-222 manufactured by Lake Region Medical.
[185702182]
Device evaluation: as received, the specimen consisted of one each hydro gw stf std s 150-035; returned loaded in the dispenser assembly within the opened, labelled packaging pouch and triple-bagged in "zip-lock" style poly biohazard pouches. The wire and dispenser assembly do not present any indication of hydration as directed in the device instructions for use. After wetting the specimen wire with blood-bank saline, the specimen was subjected to visual and tactile examination. The specimen presents a ductile, tensile overload of the polymer jacket material resulting in the removal of approximately 0. 75cm of jacket material exposing the distal 0. 75cm of the metallic core wire. The specimen also presents a large radius bend over the distal 13. 5cm. Except where noted, the specimen device appears visually and dimensionally correct. A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported. The history records indicate this product was final inspection tested and was determined to be acceptable. As indicated in the operational instructions section of the device instructions for use, "before removing the zipwire hydrophilic guidewire from the protective hoop (by its distal end), inject physiological saline solution into the hub end of the holder in order to completely wet the surface of the wire. " our investigation was unable to confirm that the product did not meet specification prior to shipment. The investigation concluded that the product met specification at the time of shipment. At this time, it is not possible to assign a definitive root cause for the event as reported. Based on the information provided to date, it appears that handling factors have contributed to the event as reported. If there is any further relevant information provided, a follow up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185702183]
It was reported that the physician unpacked the guidewire, it was found the tip of the guidewire was fractured, the metal revealed. There were no patient complications reported. The problem occured outside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126666-2020-00001 |
| MDR Report Key | 9559818 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON SEIFERT |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9526418518 |
| Manufacturer G1 | LAKE REGION MEDICAL |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIPWIRE HYDROPHILIC GUIDEWIRE |
| Generic Name | UROLOGICAL CATHETER AND ACCESSORIES |
| Product Code | EZB |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2020-01-06 |
| Model Number | M006630222B1 |
| Catalog Number | 630-222 |
| Lot Number | 11069779 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MEDICAL |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |