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 2020-01-15 for A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX UNK manufactured by Applied Medical Resources.
[177422126]
The event unit will not be returning to applied medical for evaluation. A follow-up report will be submitted upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[177422127]
Complaint 1 out of 12 (complaint #(b)(4)). Complaint 2 out of 12 (complaint #(b)(4)). Complaint 3 out of 12 (complaint #(b)(4)). Complaint 4 out of 12 (complaint #(b)(4)). Complaint 5 out of 12 (complaint #(b)(4)). Complaint 6 out of 12 (complaint #(b)(4)). Complaint 7 out of 12 (complaint #(b)(4)). Complaint 8 out of 12 (complaint #(b)(4)). Complaint 9 out of 12 (complaint #(b)(4)). Complaint 10 out of 12 (complaint #(b)(4)). Complaint 11 out of 12 (complaint #(b)(4)). Complaint 12 out of 12 (complaint #(b)(4)). Procedure performed: cabg - coronary artery bypass. Event description: the event date is unknown. "stealth clips (x12) have not been closing once applied to blood vessel. This lack of occlusion has been causing blood vessel to have blood leakage until another stealth clip can be applied. " additional information received via telephone on 31dec2019: none of the complaint clips were saved. The rep will request that the client attempt to save the product if this complaint occurs again. The clip complaints was noted over a period of time, however it is currently unclear how long this period of time was. The rep is planning to reach out to the client to determine the number of affected cases, the dates, and the procedures. Investigation for all of these stealth clips will be under investigation activity #(b)(4). Additional information received via email on 08jan2020: "i spoke with the account contact. Because this has happened over a 3 month period and they just notified on me in december, they dont have the information of dates and specific procedures that the device malfunctioned. " the three month period was clarified to be referring to october 2019 to december 2019. Additional information received via email on 13jan2020: the 12 cers were associated with model number a1603. The model number in the complaints shall be changed accordingly. Type of intervention: another stealth clip applied. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00323 |
| MDR Report Key | 9594267 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-15 |
| Date of Report | 2020-02-11 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| 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 | 2020-01-15 |
| Model Number | A1603 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-01-15 |