MAUDE Adverse Event Report: REFLOW MEDICAL, INC. SPEX LP 35, 135 CM; SUPPORT CATHETER

Model Number	SLP35135US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distal tip of spex lp 35, 135cm dislodged from the catheter body inside the sub-intimal space.
Additional Manufacturer Narrative
There was no adverse clinical impact or adverse consequence to the patient as a result of the tip separation.The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was returned for evaluation.The device was examined under microscopic magnification and a complete separation of the tip from the outer catheter was present.No medical images or medical records have been made available to the manufacturer.The initial investigation confirmed tip separation.However, the investigation to determine root cause is on-going.

• Brand Name: SPEX LP 35, 135 CM
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): REFLOW MEDICAL, INC.; 208 avenida fabricante; suite 100; san clemente CA 92672
• Manufacturer (Section G): REFLOW MEDICAL, INC.; 208 avenida fabricante; suite 100; san clemente CA 92672
• Manufacturer Contact: lori. grace ; 208 avcenida fabricante; suite 100; san clemente, CA 92672 ; 6127496031
• MDR Report Key: 18441327
• Report Number: 3008789872-2024-00001
• Device Sequence Number: 15155434
• Product Code: DQY
• UDI-Device Identifier: 00850025525022
• UDI-Public: 00850025525022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: Health Professional
• Device Expiration Date: 07/27/2025
• Device Model Number: SLP35135US
• Device Catalogue Number: SLP35135US
• Device Lot Number: 230809-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown