MAUDE Adverse Event Report: APPLIED MEDICAL A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; DXE

Model Number	A4F03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
Procedure performed unknown - "user has reported bursting of the balloon." patient status - unknown.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering confirmed that the catheter had ruptured.A review of the manufacturing records for this lot also confirmed that the product passed all manufacturing and quality inspections.All catheters undergo 100% visual inspection and leak testing during production.Similar incidents have shown that balloon rupture can occur if the inflated balloon is pulled with excessive force or if the balloon is overinflated.The instructions for use (ifu) cautions the user that "balloon degradation and rupture may result from deposits within the vessel, excessive handling, or exposure to adverse environmental conditions" and that the "maximum recommended inflation volumes should not be exceeded." although the exact root cause of the incident could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.Additional information requested and received.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: A4F03, 3F-80CM, (PREM) SYNTEL CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5682334
• Report Number: 2027111-2016-00408
• Device Sequence Number: 506757
• Product Code: DXE
• UDI-Device Identifier: 00607915111069
• UDI-Public: (01)00607915111069(17)200816(30)01(10)1253265
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K901627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2016

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: 08/16/2020
• Device Model Number: A4F03
• Device Catalogue Number: 100564901
• Device Lot Number: 1253265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2016
• Supplement Report FDA Received Date: 08/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1