MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E02, PYTHON 5MM-80CM; DXE

Model Number	A4E02
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Incident description: "please see the attached report 'amr2017-23' with picture.Event description: on (b)(6) 2017: during a preparation a medical staff tried to inflate and deflate the balloon before inserting into the patient's vessel.Then the medical staff found that the balloon didn't deflate properly.Thus, the medical staff elected to use another python catheter for the surgery.The second catheter deflated properly and the surgery was completed without any problem.This event didn't affect the patient.Comments from cosmotec:: complaint sample was returned from the hospital.The sample will be returned to applied medical.Please investigate the possible root cause.Investigation report is required for this case.On (b)(6), we tried to validate the issue.We tried to inflate and deflate the balloon several times, then we could duplicate the issue sometimes.Did the issue happen often with python catheter because the python has double lumen? or this issue happened only for this product?" type of intervention: "the medical staff elected to use another python catheter for the surgery.The second catheter deflated properly and the surgery was completed without any problem." patient status: "event didn't affect patient".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant?s experience could not be replicated or confirmed.The event unit met current specifications, and there were no visible non-conformances.Although the exact root cause of the reported event could not be determined, 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: A4E02, PYTHON 5MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6950151
• Report Number: 2027111-2017-02068
• Device Sequence Number: 16301960
• Product Code: DXE
• UDI-Device Identifier: 00607915113414
• UDI-Public: (01)00607915113414(17)201026(30)01(10)1257416
• Combination Product (Y/N): N
• PMA/510(K) Number: K970762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 10/26/2020
• Device Model Number: A4E02
• Device Catalogue Number: 100623901
• Device Lot Number: 1257416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• 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