MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; CATHETER, PRESSURE MONITORING, CARDIAC

Model Number	NAVVUS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The navvus catheter, lot number 0000160740, was received on 27sept2021.Upon completion of the investigation, a follow-up report will be submitted to fda.
Event or Problem Description
During a fractional flow reserve (ffr) procedure using the acist rapid exchange ffr system, model rxi, and navvus catheter, the navvus catheter tip broke within the patient.The tip was removed by the physician and there was no injury to the patient.
Additional Manufacturer Narrative
The navvus catheter was returned to acist for investigation.Upon removal of the navvus catheter from the packaging, visual inspection found the catheter to be separated into two pieces.The separation is located on the catheter's distal shaft, 1.5 inches from the distal tip.The separation was investigated under magnification and the separation on the distal shaft is not a clean cut.The area adjacent to the separation is deformed and damaged.The internal fiber optic cable remained intact to the distal shaft.The results of acist's investigation indicate that the catheter encountered an obstruction within the patient vasculature at the time of the catheter pull back, which resulted in the catheter separation.The damage affected the exterior of the catheter; the internal fiber optic cable was not impacted by the damage.The cause of the reported event is inconclusive.
Additional Manufacturer Narrative
Correction in field d2 for common device name in initial and follow up #1 report from "injector and syringe, angiographic, product code: dxt" to "catheter, pressure monitoring, cardiac, product: obi." in medwatch follow up #1, the manufacturer report number was incorrect on pages 2 and 3.This incorrect number has been changed from "2134243-2021-00016" to the correct manufacturer report number "2134243-2021-00018.".

• Brand Name: ACIST
• Common Device Name: CATHETER, PRESSURE MONITORING, CARDIAC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: jeff audritsh ; 7905 fuller road; eden prairie, MN 55344 ; 9529959347
• MDR Report Key: 12624950
• Report Number: 2134243-2021-00018
• Device Sequence Number: 14583380
• Product Code: OBI
• UDI-Device Identifier: 30841716102340
• UDI-Public: (01)30841716102340(11)200805(17)220805(10)0000160740
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2021
• 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
• Operator of Device: Health Professional
• Device Model Number: NAVVUS
• Device Catalogue Number: 014667
• Device Lot Number: 0000160740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 12/02/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 01/07/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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