MAUDE Adverse Event Report: AMR A4405, 4F-80CM, SYNTEL RT-EMB; DXE

Model Number	A4405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.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
Femoral cut down with thrombectomy.Possible stent placement report from customer: "catheter went through groin for access to the thrombus.Tip of balloon broke off when moving the catheter.Balloon tip broke off inside of the patient.The balloon is not on the device.They were not able to retrieve it." type of intervention: "did not open a second unit." patient status: "patient is in recovery.".
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.A visual inspection was performed using a photo was provided by the complainant.Based on the image provided, engineering observed that the tip (balloon, proximal and distal windings) had separated from the catheter.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.
Event or Problem Description
Additional information rcvd august 4th: they were trying to remove a clot & when they pulled back, the balloon was no long on the distal end of the catheter.Balloon sheared off (ended up looking like an irrigation catheter).They ended up opening the same catalog # (a4405) to successfully complete the procedure.The balloon tip is still inside the patient & the hospital staff cannot see anything under fluoroscopy.The patient has not come back into the operating room (or) (to (b)(6) knowledge).Risk management has strict orders to quarantine the device used in the event until further notice.Cole will follow up with rm to see if he can send the product back & if the patient has come back into the or for any follow ups.

• Brand Name: A4405, 4F-80CM, SYNTEL RT-EMB
• Common Device Name: DXE
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5824063
• Report Number: 2027111-2016-00538
• Device Sequence Number: 18992641
• Product Code: DXE
• UDI-Device Identifier: 00607915110840
• UDI-Public: (01)00607915110840(17)201020(30)01(10)1255541
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K901627
• 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): 05/10/2017

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: 10/20/2020
• Device Model Number: A4405
• Device Catalogue Number: 100609901
• Device Lot Number: 1255541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 05/10/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other