MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E05, PYTHON 11MM-40CM; DXE

Model Number	A4E05
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: embolectomy.Event description: "our customer complained to us for a python a4e05 device.The device broke to two pieces during withdrawing." "the catheter broke during withdrawing." three photographs are provided.The device is available for return.Additional information received via email on 08feb2018 from product specialist from (b)(4), distributor.The date applied medical was made aware of the event was 06feb2018.The date applied contacted on the cer form of 20dec2017 was the date the hospital contacted the distributor."i misunderstood the date as when the hospital contact us." type of intervention: na.Patient status: "no injury".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of device breakage.The body of the catheter was separated after the 30 cm mark.Applied medical has reviewed the details surrounding the event and returned products.At this time, applied medical is unable to determine the root cause of the event.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical is currently researching possible process enhancements, which are intended to further minimize the likelihood for this type of event to occur.

• Brand Name: A4E05, PYTHON 11MM-40CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7322512
• Report Number: 2027111-2018-00100
• Device Sequence Number: 105224
• Product Code: DXE
• UDI-Device Identifier: 00607915113445
• UDI-Public: (01)00607915113445(17)220510(30)01(10)1296020
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/29/2018

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: 05/10/2022
• Device Model Number: A4E05
• Device Catalogue Number: 100624201
• Device Lot Number: 1296020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 03/29/2018
• Patient Sequence Number: 1