MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN GUIDING CATHETER CARDIOLOGY; CATHETER, PERCUTANEOUS

Model Number XXXX

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 10/17/2013

Event Type  Injury  

Manufacturer Narrative

This complaint was identified during a recent clinical evaluation review/literature search of this device.The device is a smart control stent but the lot number is not available.The citation is as follows: nelles, m., greschus, s., möhlenbruch, m., simon, b., wüllner, u., & urbach, h.(2013).Patient selection for mechanical thrombectomy.Clinical neuroradiology, 24(3), 239-244.Complaint conclusion: as reported in the literature by nelles, m., greschus, s., möhlenbruch, m., simon, b., wüllner, u., & urbach, h.(2013).Patient selection for mechanical thrombectomy.Clinical neuroradiology, 24(3), 239-244.Doi:10.1007/s00062-013-0237-7; reports three patients with intracerebral postprocedural hemorrhage (ich) after recanalization therapy utilizing an 8 french vista brite tip guiding catheter.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) review could not be performed.The most common cause of intracerebral hemorrhage is high blood pressure (hypertension).After revascularization that alleviates a high-grade symptomatic stenotic lesion, cerebral hyperperfusion may occur as a result of a sudden, rapid increase in cerebral blood flow excess of that required to meet metabolic demands.Anticoagulation is a known risk factor for brain hemorrhage in patients with pre-existing disease.Less common causes of intracerebral hemorrhage include trauma, infections, tumors, blood clotting deficiencies, and abnormalities in blood vessels (such as arteriovenous malformations).Typically, intracerebral hemorrhage develops on the third to fifth post procedure day, though there have been cases observed immediately after surgery, as well as cases developed 3 weeks after revascularization.Given the limited information provided, and without the return of the device for analysis or procedural films, the reported event could not be confirmed, and the exact root cause could not be determined.Patient and/or pharmacological factors are also likely contributing factors.Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process.There is no evidence to suggest that the event is related to the design or manufacturing process of the device.Therefore, no preventative or corrective actions will be taken at this time.

Event Description

As reported in the literature by nelles, m., greschus, s., möhlenbruch, m., simon, b., wüllner, u., & urbach, h.(2013).Patient selection for mechanical thrombectomy.Clinical neuroradiology, 24(3), 239-244.Doi:10.1007/s00062-013-0237-7; reports three patients with intracerebral postprocedural hemorrhage (ich) after recanalization therapy utilizing an 8 french vista brite tip guiding catheter.

• Brand Name: UNKNOWN GUIDING CATHETER CARDIOLOGY
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8566819
• MDR Text Key: 143618909
• Report Number: 9616099-2019-02886
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XXXX
• Device Catalogue Number: XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening