MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4545, (5)- PACK THR-050-4F 5/BX; DXE

Model Number	A4545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
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.
Event or Problem Description
Procedure performed: "thrombectomy of dialysis graft" incident description: this cer is in correlation with (b)(4)."just had another tip break off, but not able to retrieve, still in patient." additional information was received via email from registered nurse, (b)(6) on monday, (b)(6) 2017 at 9:40 am."after inserting the fogarty through the sheath, it was inflated and pulled back per normal use.On each of the three occasions, the tip of the fogarty came off inside the graft.In the first procedure ((b)(6) 2017), the tips were able to be recovered using another fogarty while applying suction on the pigtail of the sheath.The second procedure ((b)(6) 2017) the tip was unable to be recovered.First patient no ill effects d/t the fact that the tips were recovered before flow was re-established.The second patient had no ill effect even though the tip could not be recovered." additional information was received via telephone from registered nurse, (b)(6) on monday, 16-oct-2017 at 10:38 am "i will have to check on the incident date that occurred on the first two incidents.I put the wrong product code in my email, it should be the a4545 catheter.There is no possible way for us to retrieve the tip.We will return the catheter.We also want to return the entire lot due to the number of incidents that occurred." additional information was received via telephone from registered nurse, (b)(6) on tuesday, 17-oct-2017 at 6:02 am "correction, product number is a4545.We have 15 in stock with that same lot number that we would like to send back." additional information was received via telephone from registered nurse, (b)(6) on tuesday, 17-oct-2017 at 1:52 pm "first surgery where two fogartys malfunctioned was (b)(6).Both procedures ((b)(6)) were thrombectomy of dialysis graft." patient status: "the second patient had no ill effect even though the tip could not be recovered.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of tip separation from the spring tip of the returned catheter unit.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by exposure to adverse environmental conditions within the vessel.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.

• Brand Name: A4545, (5)- PACK THR-050-4F 5/BX
• Common Device Name: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6973866
• Report Number: 2027111-2017-02076
• Device Sequence Number: 16265603
• Product Code: DXE
• UDI-Device Identifier: 00607915110925
• UDI-Public: (01)00607915110925(17)220509(30)01(10)1296500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K950586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: Other
• Device Expiration Date: 05/09/2022
• Device Model Number: A4545
• Device Catalogue Number: 100829501
• Device Lot Number: 1296500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement 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