MAUDE Adverse Event Report: CORDIS CORPORATION UNKVISTABRITEE; CATHETER, PERCUTANEOUS

Model Number UNK-CARDIOLOGY GUIDING CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Hematoma (1884)

Event Date 10/05/2011

Event Type  Injury  

Manufacturer Narrative

This article was found during a recent clinical evaluation review/literature search of this device.The report also represents notification of two events for basal ganglia infarction and basal ganglia hematoma.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The devices are vista brite guiding catheters but the catalog and lot numbers are not available.As reported in the literature by möhlenbruch, m., seifert, m., okulla, t., wüllner, u., hadizadeh, d.R., nelles, m., urbach, h.(2011).Mechanical thrombectomy compared to local-intraarterial thrombolysis in carotid t and middle cerebral artery occlusions.Clinical neuroradiology, 22(2), 141-147.Doi:10.1007/s00062-011-0099-9; reports two patients that suffered from basal ganglia infarction despite full recanalization using a 8 french vista brite tip guiding catheter and showed basal ganglia hematoma on a 24 hour ct.During the procedure, the vista brite tip catheter was placed in the proximal internal carotid artery using the transfemoral approach.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Procedures requiring biopsy forceps should not be attempted by physicians unfamiliar with the possible complications.Basal ganglia infarction is a known potential adverse event associated with carotid stent implantation procedures.The act of angioplasty/stent implantation inherently produces a localized vessel injury, including plaque compression and splitting, potentially leading to release of atheromatous material (lesion contents) into the downstream flow and potentially slowing or completely occluding the blood flow.Basal ganglia infarction can cause serious post-procedural complications of stent occlusion or distal embolization, resulting in acute cerebral infarction.Acute stent thrombosis rate is reported to be approximately 0.5%.In the cavatas (carotid and vertebral artery transluminal angioplasty study) trial, stroke occurred in 5% of patients immediately or soon after balloon dilatation and stenting.Although the incidence of stroke attributable to acute stent thrombosis is unclear, a substantial proportion is assumed to be a direct result of stent thrombosis or an indirect result by distal embolization.Several factors, including mechanical plaque disruption, intimal injury, and stent thrombogenicity predispose the patient to thromboembolic events.Platelet adhesion, activation, and aggregation play main roles in mural thrombus formation.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.

Event Description

As reported in the literature by möhlenbruch, m., seifert, m., okulla, t., wüllner, u., hadizadeh, d.R., nelles, m., urbach, h.(2011).Mechanical thrombectomy compared to local-intraarterial thrombolysis in carotid t and middle cerebral artery occlusions.Clinical neuroradiology, 22(2), 141-147.Doi:10.1007/s00062-011-0099-9; reports two patients that suffered from basal ganglia infarction despite full recanalization using a 8 french vista brite tip guiding catheter and showed basal ganglia hematoma on a 24 hour ct.During the procedure, the vista brite tip catheter was placed in the proximal internal carotid artery using the transfemoral approach.

• Brand Name: UNKVISTABRITEE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8607471
• MDR Text Key: 144961466
• Report Number: 9616099-2019-02930
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CARDIOLOGY GUIDING CATHETER
• Device Catalogue Number: UNK-CARDIOLOGY GUIDING CATHETE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• 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