MAUDE Adverse Event Report: AMR A4E08, PYTHON 13MM-80CM; DXE

Model Number	A4E08
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided 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.
Event or Problem Description
(b)(4).Procedure performed: tver.Embolization was found in the left subclavian vessel of the patient.In order to coil at the site of embolization, the physician used python as a sheath.During this, the guide wire popped out from the python shaft body.Another python was opened and used for the second try.The second python worked well.The operation was successfully completed.Comments from cosmotec - "one (1) unit of python catheter was returned from the customer.We confirmed the device and found that there was a hole on the catheter shaft, near the black single marker at the distal side.The sample is available for an investigation.It can be returned to applied medical." patient status: there was no impact to the operation.No health damage has been reported with the patient.Additional information received: june 17, 2016.Was the guide wire being inserted or removed when the guide wire popped out? when the guide wire popped out, both the catheter and the guide wire was removed from the patient vessel.The customer opened new catheter and continued the operation.What guide wire was being used with this catheter? the customer used radifocus guidewire, angled type, made by terumo.What size was the guide wire? 0.035".Was the catheter inspected prior to use? yes, the catheter was inspected prior to use.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a hole in the shaft of the catheter.Testing was performed on a representative sample in order to try and replicate the complainant's experience.Engineering was able to replicate the complainant's experience by bending the catheter body and inserting the guide wire against the inner wall of the catheter.Therefore, it is likely that the hole was caused by an instrument.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.
Event or Problem Description
Additional information rcvd sept 25, 2016: either model: rf-ga35183¿rf-ga35263¿rf-ga35303 was used in the procedure from termo website.The tip of the guidewire used was the tip which has angle was inserted first toward the balloon of python.They found the guidewire coming out from the python shaft during the insertion of the guidewire outside of the vessel.It is not possible to obtain product number sample to investigate as (b)(4) asked applied to purchase on our their side.

• Brand Name: A4E08, PYTHON 13MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5749452
• Report Number: 2027111-2016-00480
• Device Sequence Number: 16144204
• Product Code: DXE
• UDI-Device Identifier: 00607915113476
• UDI-Public: (01)00607915113476(17)170719(30)01(10)1174803
• 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: 07/19/2017
• Device Model Number: A4E08
• Device Catalogue Number: 100624501
• Device Lot Number: 1174803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2016
• 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