MAUDE Adverse Event Report: APPLIED MEDICAL A4E01, PYTHON 5MM-40CM; DXE

Model Number	29
Medical Device Problem Codes	Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2016
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.
Event or Problem Description
Angioplasty/declot of access - "product was defective".Type of intervention: removal of product.Patient status - "pt.Doing well / pt.Has been reschedule for procedure in office".
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon inspection, engineering found that the body tubing was damaged at the inflation hub junction.The root cause of the customer's complaint about a defective product is most likely the damage to the inflation hub junction.This component damage prohibited the balloon from inflating.This type of damage can be caused by improper handling during use.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Patient status - pt.Doing well/pt.Has been rescheduled for procedure in office.

• Brand Name: A4E01, PYTHON 5MM-40CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5621630
• Report Number: 2027111-2016-00346
• Device Sequence Number: 10836138
• Product Code: DXE
• UDI-Device Identifier: 00607915113407
• UDI-Public: (01)00607915113407(17)201111(30)01(10)1259463
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 29
• 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): 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/11/2020
• Device Model Number: 29
• Device Catalogue Number: 29
• Device Lot Number: 1259463
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention