MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4E04, PYTHON 9MM-80CM; DXE

Model Number	A4E04
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Based on the description of the event, it is likely that the reported event was caused by exposure to adverse environmental conditions within the vessel.However, in the absence of the event unit, it is difficult to determine the exact root cause of the event.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
Procedure performed: "emergency thrombectomy" (b)(4).No complaint sample was returned from hospital, but (b)(6) would like applied medical to issue one (1) python catheter credit memo for this case.(on (b)(6) 2017: during a procedure) an emergency thrombectomy was performed.The physician suspected that thrombus/thrombi are sclerosed.The physician prepared three (3) python catheters for the procedure.All three of the python catheters were ruptured when the physician tried to remove the thrombus/thrombi from a blood vessel.The physician elected to use another catheter for the procedure.Additional information received by email at 10:32 pm on (b)(6) 2017 from regulatory affairs: this was not a robotic case.The balloon did not occlude the vessel.There was no damage to the vessel.Did the catheter come into contact with any sharp objects throughout the procedure? according to the information from the customer, the patient has thrombus/thrombi calcification.Did the surgeon have any difficulty inserting or removing the catheter? -we couldn't get this information from the surgeon.There wasn't any unintended material left in the patient.Could you provide the reason why the three catheters are not available to be returned? -because the complaint samples were discarded in the hospital.Additional information received by email at 2:13 am on 17-nov-2017 from regulatory affairs: was the balloon inspected before the start of the procedure? -according to the sales reps., it was an emergency surgery, so it's not clear the surgeon inspected the balloon before inserting.Was there an attempt to inflate the balloon before the start of the procedure? same answer as above.Type of intervention: "the physician elected to use another catheter for the procedure." patient status: "no health damage was reported for the patient.".

• Brand Name: A4E04, PYTHON 9MM-80CM
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7085401
• Report Number: 2027111-2017-02124
• Device Sequence Number: 16627507
• Product Code: DXE
• UDI-Device Identifier: 00607915113438
• UDI-Public: (01)00607915113438(17)211101(30)01(10)1281786
• 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
• Report Date (Section B): 12/05/2017

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: Physician
• Device Expiration Date: 11/01/2021
• Device Model Number: A4E04
• Device Catalogue Number: 100624101
• Device Lot Number: 1281786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/05/2017
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1