MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-11 for A1704, 6MM S/S STLTH CLP N/S 3/4 F 50/BG 100579801 manufactured by Applied Medical Resources.
[64546492]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A follow-up report will be sent once the results have been analyzed. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[64546493]
Open heart cabg - "customer reported clips, spring surgical stealth, repeatedly flew off the end of the patient's vein each time they tried to dilate, and it does not perform up to the standard needed to do the surgery. " additional information received via email on january 03, 2016 - the entire clip came off the vessel. The clip was retrieved. The pa had no trouble placing the clip. Originally, the clip occluded the vein, however when the pa tried to dilate the vein, the clip came off. The pa was preparing the vein for a bypass graft. Staff did not seem to believe there was damage to the graft vessel. Another clip was opened to the field. The item is not available for return. Patient status: no adverse effects reported as a result of this complaint.
Patient Sequence No: 1, Text Type: D, B5
[74825209]
The event unit was not returned to applied medical for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2017-00014 |
| MDR Report Key | 6241534 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-11 |
| Date of Report | 2017-05-02 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2017-01-11 |
| 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 | JENNIFER SCOULLAR |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A1704, 6MM S/S STLTH CLP N/S 3/4 F 50/BG |
| Generic Name | DSS |
| Product Code | DSS |
| Date Received | 2017-01-11 |
| Model Number | A1704 |
| Catalog Number | 100579801 |
| Lot Number | 1184100 |
| Device Expiration Date | 2017-11-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |