MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4545, (5)- PACK THR-050-4F 5/BX; DXE

Model Number	A4545
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Incident description: "the tip broke off." additional information was received via email from rn, (b)(6) on friday (b)(6) 2017 at 6:21 am: "thrombectomy catheter inserted through merit 8f sheath (pss-8f-4mt) into the brachial artery.Inflated and pulled back to tip of sheath, deflated and removed.This was down successfully twice.On the third time, the tip of the catheter came off inside the patient's graft.New catheter (a4f04) was used to try to retrieve the tip, but was unsuccessful.At this time, there is no ill effect to the patient.The faulty product was not saved to be returned.Type of intervention: none.Patient status: "there is no ill effect to the patient.".
Additional Manufacturer Narrative
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.

• Brand Name: A4545, (5)- PACK THR-050-4F 5/BX
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7068026
• Report Number: 2027111-2017-02128
• Device Sequence Number: 10788631
• Product Code: DXE
• UDI-Device Identifier: 00607915110925
• UDI-Public: (01)00607915110925(17)220806(30)01(10)1303010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K950586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/06/2022
• Device Model Number: A4545
• Device Catalogue Number: 100829501
• Device Lot Number: 1303010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/05/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1