MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC VENTURE OTW; CATHETER

Model Number 5821

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 07/17/2019

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were no nonconformances related to this lot.Based on the reported event details it is most likely that the venture was withdrawn without first deactivating the deflectable tip.The ifu warns to deactivate the venture deflectable tip prior to tracking over the guidewire to prevent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 operating room 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 2134812-2019-00060 submission is associated to this mdr.

• Brand Name: VENTURE OTW
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8941072
• MDR Text Key: 155851767
• Report Number: 2134812-2019-00059
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10841156102241
• UDI-Public: (01)10841156102241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: 5821
• Device Catalogue Number: 5821
• Device Lot Number: 644680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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): Death
• Patient Age: 79 YR
• Patient Weight: 75