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 2020-01-07 for A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX 101374101 manufactured by Applied Medical Resources.
[177625364]
Ra has just received the incident device and has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[177625365]
Complaint 1 of 2: (b)(4) - clip 1. Complaint 2 of 2: (b)(4) - clip 2. Procedure performed: heart procedure. Limited information available at the time of the report. In the middle of the procedure they were trying to place 2 stealth spring clips and they would not stay closed. These clips were removed. They pulled 2 more clips from another lot number, these did stay closed and case completed. There was no damage to the vessel. There was no loss of occlusion due to the clips not staying closed. The clips are available for return. Intervention: replaced with new clip of a different lot number. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00302 |
| MDR Report Key | 9561727 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2019-06-04 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX |
| Generic Name | CLIP, VASCULAR |
| Product Code | DSS |
| Date Received | 2020-01-07 |
| Returned To Mfg | 2020-01-02 |
| Model Number | A1603 |
| Catalog Number | 101374101 |
| Lot Number | 1357103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-07 |