MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-04-21 for TRAXCESS 14 GUIDEWIRE N/A GW1420040 manufactured by Terumo Corporation, Ashitaka.
[5724852]
The user facility reported a foreign substance found in the rhv (rotating hemostatic valve) of the device. Follow up communication with the user facility reported the following information: a scepter and traxcess device was being prepared; and it was then, that a little piece of metal was found in the rhv.
Patient Sequence No: 1, Text Type: D, B5
[13232434]
The actual sample along with the foreign substance was returned to the manufacturing facility for evaluation. Visual and magnifying inspections of the foreign substance confirmed that the substance was blue in color. The substance was approximately 24mm in length and confirmed be ptfe (polytetrafluoroethylene). The obtained substance was found to be that of the same as that of the current traxcess sample. Visual inspection of the actual sample did not find any kink or dent on the shaft. Magnifying inspection found that the actual sample had been sheared off on the segments as follows: approximately 1389 - 1413mm from the distal end (approximately 24mm); approximately 1800 - 1810mm from the distal end (approximately 10mm); and approximately 1822 - 1853mm from the distal end (approximately 31mm). The actual sheared off sections totaled, approximately 65mm in length. The length of the foreign substance returned measured approximately 24mm. From these findings it is likely that approximately 41mm in length of the foreign substance is missing. The outside diameter was measured on the undamaged segment and confirmed to meet manufacturing specifications. An attempt was made to insert the actual sample into a factory reserved scepter sample. The actual sample was found to be inserted through the scepter along the total length with no resistance being perceived or no shearing of the shaft being occurred during advancement. Review of the device history record and the shipping inspection record of the involved product/lot# confirmed there were not any indications of production related problems or discrepancies in the inspection results. A search of the complaint files confirmed that this product/lot# combination has not been reported previously. Simulation testing was conducted. A factory retained traxcess sample was let to come in close contact with the edge of a metal made object and in this state it was pulled in the proximal direction. The shaft of the traxcess sample got sheared off. There is no evidence that this event was related to a device defect or malfunction. Although the exact cause cannot be determined based on the available information provided by the user facility the event description it is likely that the actual traxcess sample was abraded with a rigid object and sheared off. All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681834-2015-00065 |
| MDR Report Key | 4710430 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-04-21 |
| Date of Event | 2014-12-30 |
| Date Facility Aware | 2014-12-30 |
| Report Date | 2015-03-30 |
| Date Reported to Mfgr | 2015-03-30 |
| Date Mfgr Received | 2015-03-30 |
| Device Manufacturer Date | 2014-07-18 |
| Date Added to Maude | 2015-04-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CATHLEEN HARGREAVES |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Street | 150 MAIMAIGI-CHO |
| Manufacturer City | FUJINOMIYA CITY, SHIZUOKA 418 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 418 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAXCESS 14 GUIDEWIRE |
| Generic Name | GUIDEWIRE |
| Product Code | MOF |
| Date Received | 2015-04-21 |
| Returned To Mfg | 2015-03-30 |
| Model Number | N/A |
| Catalog Number | GW1420040 |
| Lot Number | 140718 |
| ID Number | N/A |
| Device Expiration Date | 2017-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION, ASHITAKA |
| Manufacturer Address | 150 MAIMAIGI-CHO FUJINOMIYA CITY, SHIZUOKA 418 JA 418 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-21 |