MAUDE Adverse Event Report: ARROW- INTERNATIONAL, INC. ARROW-TREROTOLA EMBOLECTOMY 5 FR CATHETER 65 CM LENGTH; 9MM; ARROW-TREROTOLA EMBOLECTOMY CATHETER

Model Number PT-65509

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  Injury  

Event Description

During an avf declot the arrow-trerotola embolectomy catheter ref # (b)(4), lot # 13f19f0437 soft tip fell off inside the patient.Medical doctor was able to retrieve the tip using a snare.A second trerotola was opened nad the same thing occurred.Md was able to retrieve the tip using a snare.Since the issue occurred with two separate catheters with the same lot #.The remaining inventory with lot # 13f19f0437 was pulled off the shelf immediately.A third trerotola with a different lot # was then opened and worked perfectly.Two defective devices available for inspection.Fda safety report id # (b)(4).

• Brand Name: ARROW-TREROTOLA EMBOLECTOMY 5 FR CATHETER 65 CM LENGTH; 9MM
• Type of Device: ARROW-TREROTOLA EMBOLECTOMY CATHETER
• Manufacturer (Section D): ARROW- INTERNATIONAL, INC.
• MDR Report Key: 9467123
• MDR Text Key: 171629453
• Report Number: MW5091655
• Device Sequence Number: 2
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT-65509
• Device Lot Number: 13F19F0437
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73