A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX UNK

MAUDE Adverse Event Report

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 2020-01-14 for A1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX UNK manufactured by Applied Medical Resources.

Event Text Entries

[177620334] No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10


[177620335] 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. "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 from account manager: 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. Additional information received via email on 08jan2020 from account manager: "i [name] spoke with the account contact. Because this has happened over a 3 month period and they just notified on me in december, they do t 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. Intervention: another stealth clip applied. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027111-2020-00310
MDR Report Key9589003
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-14
Date of Report2020-02-06
Date Mfgr Received2019-12-17
Date Added to Maude2020-01-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWENDY KOBAYASHI
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138059
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameA1603, 6MM L/L STEALTH CLIP 3/4 F 10/BX
Generic NameCLIP, VASCULAR
Product CodeDSS
Date Received2020-01-14
Model NumberA1603
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL RESOURCES
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-14

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