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

Model Number	A4545
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
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.Incident description: after dr.Grant went to insufflate balloon, he passed it through the vessel and after pulling balloon out, he noticed the balloon was ruptured.It was noted there was some kind of small fiber attached to the balloon.This happened in the beginning of the case.The catheter did not come into contact with any sharp objects throughout the case.Patient status: there was no patient injury.
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.Upon visual inspection, engineering observed the proximal winding was partially unwound.Engineering could not confirm the complainant's experience of a ruptured balloon as the balloon was able to be inflated.Based on the condition of the returned unit, it is likely that the proximal thread had become unwound due to insufficient adhesive applied to the proximal winding during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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
Add info received via mail from (b)(6) on july 17, 2017 - the balloon was inspected prior to the start of the procedure, but there was not an attempt to inflate the balloon prior to the start of the procedure.The balloon did not occlude the vessel.No damage occurred to the vessel.There was no difficulty inserting or removing the catheter.No unintended material was left in the patient.The surgeon pulled another fogarty to complete the case.

• 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: 6672064
• Report Number: 2027111-2017-01884
• Device Sequence Number: 1080316
• Product Code: DXE
• UDI-Device Identifier: 00607915110925
• UDI-Public: (01)00607915110925(17)220214(30)01(10)1289288
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/29/2017

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: 02/14/2022
• Device Model Number: A4545
• Device Catalogue Number: 100829501
• Device Lot Number: 1289288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other