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

Model Number	A4E05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
"(b)(4)." "(on (b)(6) 2016: during a surgery) the complaint catheter was used for a thrombectomy operation for an artificial blood vessel.A medical staff inspected the catheter prior to use and no problem was found.The catheter was inserted into a patient vessel to the proper position.Then the catheter was inflated, the catheter balloon ruptured.This event didn't affect the patient.However, the medical staff concerns the possibility that pieces of catheter balloon were left inside the patient body or not." "comments from (b)(4): one (1) unit of catheter was returned from the hospital.We confirmed the device and found that there was a slit on the catheter balloon.The sample will be returned to applied medical.Please investigate the possible root cause and possibility of the residual pieces of catheter balloon left in the patient or not.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the balloon had ruptured.There was no evidence of balloon fragmentation.Based on the description of the event, the balloon was inspected prior to the procedure, which implies that the product was likely conformant before use.It is likely that the unit was inflated and pulled with a force exceeding what the balloon was able to withstand or was subjected to adverse conditions within the vessel.The instructions for use (ifu) states "balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel." 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: 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: 6262240
• Report Number: 2027111-2017-00032
• Device Sequence Number: 828611
• Product Code: DXE
• UDI-Device Identifier: 00607915113445
• UDI-Public: (01)00607915113445(17)180102(30)01(10)1181977
• 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): 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: 01/02/2018
• Device Model Number: A4E05
• Device Catalogue Number: 100624201
• Device Lot Number: 1181977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• 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