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Model Number 5821
Device Problem Use of Device Problem (1670)
Patient Problems Death (1802); Vascular Dissection (3160)
Event Date 07/25/2019
Event Type  Death  
Manufacturer Narrative
No devices were returned for evaluation. Manufacturing records were reviewed and there were no nonconformances related to this lot. Based on the reported event details it is most likely that the venture was withdrawn without first deactivating the deflectable tip. The ifu warns to deactivate the venture deflectable tip prior to tracking over the guidewire to prevent potential vessel injury.
Event Description
Site reported there was a difficult lesion in the left main coronary artery, and significantly angled lad. Physician attempted access to the lad with multiple catheters and then attempted with venture but was unsuccessful. Site reported in trying difficult navigation venture may have hooked or penetrated a vessel layer and caused a dissection, unsure from imaging if it was a true dissection. The patient was sent to emergent cabg and expired 2 days after emergent cabg. User identified unfamiliarity with the catheter as contributory cause. Per medwatch uf/importer report # (b)(4) submitted on 05aug19 to fda from site: (b)(6) yo male admitted on (b)(6) with nstemi, underwent cardiac cath (b)(6) showing total occlusion of rca and 70% occlusion of lad. Pt and family decided to pursue pci versus cabg. On (b)(6) pt underwent 2nd cath for stent deployment. Attempt to wire the lad was unsuccessful, resulting in attempt to access the vessel using the venture catheter. At this time the patient decompensated, and it was determined that the lad was dissecting. Pt required pressures and brief cpr. He was taken emergently to the or for a salvage cabg. Also, concern for a development of a thrombus. Post op ef was 10%. Pt admitted to sicu in cardiogenic shock and expired on (b)(6). User identified his unfamiliarity with the catheter, specifically in careful manipulation of the curved tip of the catheter in the coronary arteries, as a contributing cause of the patient's decompensation. 100% occluded rca, 50% occluded lm, & 70% occluded lad. Two venture catheters were reported used in the procedure, it is unknown which is associated with the event. Second mdr 2134812-2019-00059 submission is associated to this mdr.
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Type of DeviceCATHETER
Manufacturer (Section D)
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
mary haufek
6464 sycamore court north
minneapolis, MN 55369
MDR Report Key8941210
MDR Text Key155859946
Report Number2134812-2019-00060
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/15/2021
Device Model Number5821
Device Catalogue Number5821
Device Lot Number646767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/28/2019 Patient Sequence Number: 1