MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E04, PYTHON 9MM-80CM; DXE

Model Number	A4E04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Thrombectomy - proximal tip where the hub is, snapped - "the blue portion." x-ray tech was able to thread over the wire and when the doctor tried to inflate the balloon, the proximal end snapped - everything was fine during prep.No unintended material entered patient." patient status - "no impact to patient." type of intervention - "opened a second unit.Second unit worked as expected." additional information received via email from (b)(6) on august 4, 2016 - no excessive force for this incident, but customer did say that there have been / are times when the catheter is difficult to thread.No blockage when inserting the guide wire.Nothing different noticed for the 2nd unit.No lot number for the 2nd unit.They did not thread the wire during prep.The contrast solution is 50% saline and 50% omnipaque contrast.The guidewire used was terumo (gr3506, gs3506), newton guidewire, usually.035 diameter.
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event product was returned for evaluation.Upon inspection, engineering noted that the catheter was defective at the guide wire luer hub junction.All catheters devices undergo 100% hub assembly leak test inspection and visual inspection during the manufacturing and assembly process.The exact root cause of the event is unknown; in order to break the catheter hub from the body, a considerable amount of force must be placed on the catheter.Applied medical will continue to monitor its vigilance systems and take appropriate actions, where needed.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: A4E04, PYTHON 9MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5883849
• Report Number: 2027111-2016-00589
• Device Sequence Number: 13784588
• Product Code: DXE
• UDI-Device Identifier: 00607915113438
• UDI-Public: (01)00607915113438(17)210106(30)01(10)1262756
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K970762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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: 01/06/2021
• Device Model Number: A4E04
• Device Catalogue Number: 100624101
• Device Lot Number: 1262756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1