MAUDE Adverse Event Report: NITILOOP LTD NOVACROSS MICROCATHETER; PERCUTANEOUS CATHETER

Model Number NOVACROSS XTREME

Device Problem Fracture (1260)

Patient Problems Peripheral Vascular Disease (2002); No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

The physician used the device in an extreme condition, in a highly calcified lesion below the knee.

Event Description

Tip of device broke off in calcaneal artery.Left in place.The user placed a stent to attach the tip to the artery endothelium.Procedure completed successfully.

• Brand Name: NOVACROSS MICROCATHETER
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): NITILOOP LTD; 1 tidhar; pardes hanna, ha zafon, 37110 01; IS 3711001
• Manufacturer (Section G): NITILOOP LTD.; 1 tidhar; pardes hanna ha zafon, 37010 00; IS 3701000
• Manufacturer Contact: amir pansky / itamar haran ; 1 tidhar; pardes hanna ha zafon, 37110-01 ; IS 3711001
• MDR Report Key: 9711168
• MDR Text Key: 197994569
• Report Number: 3011816495-2020-00001
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 07290017436012
• UDI-Public: 07290017436012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: NOVACROSS XTREME
• Device Catalogue Number: A02-108
• Device Lot Number: FP.000042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 80