MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER 7F X 65CM 15MM AMPLITUDE; CLEANER15

Model Number	700015
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.A follow-up report will be provided once the sample has been reviewed.
Event or Problem Description
The staff notified me that they had a thrombectomy device cleaner malfunction on them during a case with dr.(b)(6) yesterday.When they entered it in the vein the tip got stuck and when they tried to pull it out the tip broke off in the patient.They tried to put a balloon past it to get it out but were not successful.They had to leave the tip in the patient.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: CLEANER 7F X 65CM 15MM AMPLITUDE
• Common Device Name: CLEANER15
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11166970
• Report Number: 1625425-2021-00817
• Device Sequence Number: 4532645
• Product Code: KRA
• UDI-Device Identifier: 00886333222315
• UDI-Public: 00886333222315
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: K141617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: 700015
• Device Catalogue Number: 700015
• Device Lot Number: REF200042/1
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other