MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CE0380ST, 3F-80CM PREM SYNTEL CATH; DXE

Model Number	CE0380ST
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted that the balloon had ruptured without fragmentation.During the manufacturing process, all catheters are 100% leak tested and visually inspected prior to packaging.The root cause of the event is likely due to an external force exerted on the balloon, while inflated, that exceeded the material strength of the balloon.As stated in the instructions for use (ifu), "balloon degradation and rupture may result from deposits within the vessel, excessive handling, or exposure to adverse environmental conditions." although the root cause could not be confirmed, 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.In accordance with 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.This report represents the initial and final report.Based on the description of balloon leakage during initial intake of the complaint, the event was not reported as it was unlikely to cause or contribute to death or serious injury.After engineering performed their evaluation, the event is now deemed reportable.
Event or Problem Description
Hernia by coelioscopy - "it was reported that there a leak on the balloon.Device used on patient.No patient injury is reported." additional information received via email on july 8, 2016: the device was inspected prior to the procedure.The leak was found during insertion.The procedure that was being performed was a hernia by coelioscopy.Patient status: "patient is ok.".

• Brand Name: CE0380ST, 3F-80CM PREM SYNTEL CATH
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6179653
• Report Number: 2027111-2016-00900
• Device Sequence Number: 13681584
• Product Code: DXE
• UDI-Device Identifier: 00607915117467
• UDI-Public: (01)00607915117467(17)200324(30)01(10)1243293
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K901627
• 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
• Report Date (Section B): 12/15/2016

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: 03/24/2020
• Device Model Number: CE0380ST
• Device Catalogue Number: 100745201
• Device Lot Number: 1243293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1