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	10/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of 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
Procedure performed unknown - "having problems feeding terumo glides through the fogerty and the balloon end broke off in a patient's artery.It was described that 4in of the tip broke off.The physician was able to retrieve the tip with a snare." patient status - no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the catheter was separated into the three sections.The end of the first section (tip) was stretched and deformed, while the ends of the second and third sections were cleanly cut.Testing was performed and there were no non-conformances related to the inner diameter of the event unit.The exact root cause of the event could not be determined, as engineering was unable to confirm the complainant's experience of having problems feeding the guide wire into the event unit and replicate the breakage that was observed on the event unit.Additional information was requested, however, none has been provided at this time.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.

• 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: 6246237
• Report Number: 2027111-2016-00779
• Device Sequence Number: 426267
• Product Code: DXE
• UDI-Device Identifier: 00607915113438
• UDI-Public: (01)00607915113438(17)210816(30)01(10)1276316
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: 08/16/2021
• Device Model Number: A4E04
• Device Catalogue Number: 100624101
• Device Lot Number: 1276316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1