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

Model Number	NAVVUS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The navvus catheter, lot: 0000106138, serial number: (b)(4), was received at acist on april 1, 2019, and was analyzed.Following are the results of acist's analysis of the navvus catheter: the navvus catheter was found separated at where the distal shaft is bonded to the mid-shaft, approximately 26cm from the distal tip.A 10cm split running along the side of the catheter was observed.The split started from the rx port where the guidewire enters the catheter, towards the distal end of the catheter.The edges of the split were jagged and not a clean cut.The fiber optic cable of the navvus catheter was also found to be fractured and separated at the distal shaft/mid-shaft bond region.An acist medical advisor contacted the physician from the user facility to obtain additional information on the event.According to the physician who experienced the issue, an attempt was made to withdraw the navvus catheter from the right coronary artery (rca) when he noticed the tip was not moving.He removed the navvus catheter from the guide catheter, over the guidewire, and found the tip was detached.He then advanced a balloon over the wire (still in the coronary) and inflated the balloon near the guide catheter tip, thereby trapping the proximal end of the navvus catheter that was still in the guide catheter.He pulled on the guide catheter and removed the navvus catheter from the coronary (and then from the body).Based on the investigation performed by acist, feedback from the acist medical advisor, and information obtained by the physician at the user facility; the likely cause of the navvus catheter separation was a guidewire which became entangled in the guidewire entry (rx) port of the catheter.When the navvus catheter was pulled to withdraw from the patient's rca, the guidewire caught near the rx port which resulted in the splitting of the catheter shaft from the rx port 10cm towards the distal end of the catheter.Additional information attached to this medwatch are acist's responses to fda's questions related to this event and the (b)(4)medwatch, mw5084958.- [acist response to fda mw5084958.Pdf].
Event or Problem Description
During an interventional procedure using the acist rapid exchange ffr system, model rxi, with navvus catheter, on a patient with calcified and tortuous target artery, the navvus catheter tip separated during use.The user was able to retrieve the tip using a snare device.There was no reported injury to the patient.A new navvus catheter was used to complete the procedure with no additional issues.
Additional Manufacturer Narrative
Correction to initial report.Initial reporter occupation is "other health professional".

• Brand Name: ACIST
• Common Device Name: CATHETER, PRESSURE MONITORING, CARDIAC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 8532010
• Report Number: 2134243-2019-00007
• Device Sequence Number: 2430988
• Product Code: OBI
• UDI-Device Identifier: 30841716101244
• UDI-Public: 30841716101244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 09/23/2019
• Device Model Number: NAVVUS
• Device Catalogue Number: 014667
• Device Lot Number: 0000106138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE (MFR., MODEL, LOT NUMBER NOT PROVIDED)