MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4406, 5F-80CM, SYNTEL RT-EMB; DXE

Model Number	A4406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2016
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
"(please refer to cer (b)(4) a4406 - lot 1249201 - 1) balloon was checked by inflating it out from patient and no problem, it inflated regularly.Catheter was used on patient and inflated with 0,75cc physiologic solution.Also in this case, they could feel no any resistance so they extracted it and could feel no any resistance.After extraction they could see ballon was deflated (they do not tried to inflate it again to check if it was broken).Catheter was substituted with another one, different brand was used (brand n/a) sample is available for inspection event was transmitted to us as "complaint." additional information received: procedure was aorto bifemoral bypass.Catheters were used for prosthesis thrombectomy.They report no prosthesis calcification at all found in the vessel.Patient status - good, no additional intervention required.
Additional Manufacturer Narrative
Type of intervention added to description.Additional information was requested and received.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the experience of balloon rupture without fragmentation.No testing was performed on the returned unit due to the compromised integrity of the balloon.All applied medical catheters are functionally tested throughout the manufacturing process to ensure proper function.The customer confirmed that the balloon was inflated and retained air outside of the patient.This implies that the product was conforming before use.The exact root cause of the customer's experience remains unknown.Similar events have shown that balloon rupture can occur when the balloon is inflated and pulled with a force that exceeds that material strength of the balloon or if the balloon is over-inflated.The instructions for use (ifu) warn that, "balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel." although the exact root cause remains unknown, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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
Type of intervention - "they just changed catheter".

• Brand Name: A4406, 5F-80CM, SYNTEL RT-EMB
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6039027
• Report Number: 2027111-2016-00697
• Device Sequence Number: 10969294
• Product Code: DXE
• UDI-Device Identifier: 00607915110857
• UDI-Public: (01)00607915110857(17)200616(30)01(10)1249201
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/14/2016

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: 06/16/2020
• Device Model Number: A4406
• Device Catalogue Number: 100610001
• Device Lot Number: 1249201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 11/17/2016
• Patient Sequence Number: 1