MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for ACIST NAVVUS 014667 manufactured by Acist Medical Systems, Inc..
[147616587]
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].
Patient Sequence No: 1, Text Type: N, H10
[147616588]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134243-2019-00007 |
| MDR Report Key | 8532010 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-09-24 |
| Date Added to Maude | 2019-04-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFF AUDRITSH |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9529959347 |
| Manufacturer G1 | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 7905 FULLER ROAD |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55344 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACIST |
| Generic Name | CATHETER, PRESSURE MONITORING, CARDIAC |
| Product Code | OBI |
| Date Received | 2019-04-19 |
| Returned To Mfg | 2019-04-01 |
| Model Number | NAVVUS |
| Catalog Number | 014667 |
| Lot Number | 0000106138 |
| Device Expiration Date | 2019-09-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACIST MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 7905 FULLER ROAD EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |