MAUDE Adverse Event Report: CORDIS CORPORATION BIOPSY FORCEPS 5.5F STD 104CM; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number 504300

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

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows: tyler z, guttmann op, dhinoja m, oro r, savvatis k, mohiddin s, sekhri n, lopes l, patel v, jones da, bourantas cv, mathur a, elliott pm, o'mahony c.The safety and feasibility of transitioning from transfemoral to transradial access left ventricular endomyocardial biopsy.J invasive cardiol.2020 dec;32(12):e349-e354.Epub 2020 nov 10.Pmid: 33168780.Specific product details are not available.The exact event date is unknown.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported in the literature article by tyler z, guttmann op, dhinoja m, oro r, savvatis k, mohiddin s, sekhri n, lopes l, patel v, jones da, bourantas cv, mathur a, elliott pm, o'mahony c.The safety and feasibility of transitioning from transfemoral to transradial access left ventricular endomyocardial biopsy.J invasive cardiol.2020 dec;32(12):e349-e354.Epub 2020 nov 10.Pmid: 33168780., one patient developed pericardial effusion with tamponade after 1 biopsy sample was taken with a 5f, 104cm cordis bioptome biopsy forceps via the right radial artery.Pericardiocentesis was performed, blood was transfused, and the bleeding settled without the need for surgery.The cordis bioptome was then advanced through the unknown mp guide catheter into the left ventricular (lv) cavity.Samples were obtained with fluoroscopic guidance.Repetitive bleed-back and manual flushing were undertaken.The device will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported in the literature article by tyler z, guttmann op, dhinoja m, oro r, savvatis k, mohiddin s, sekhri n, lopes l, patel v, jones da, bourantas cv, mathur a, elliott pm, o'mahony c.The safety and feasibility of transitioning from transfemoral to transradial access left ventricular endomyocardial biopsy.J invasive cardiol.2020 dec;32(12):e349-e354.Epub 2020 nov 10.Pmid: (b)(4)., one patient developed pericardial effusion with tamponade after 1 biopsy sample was taken with a 5f, 104cm cordis bioptome biopsy forceps via the right radial artery.Pericardiocentesis was performed, blood was transfused, and the bleeding settled without the need for surgery.The cordis bioptome was then advanced through the unknown mp guide catheter into the left ventricular (lv) cavity.Samples were obtained with fluoroscopic guidance.Repetitive bleed-back and manual flushing were undertaken.The device was not returned for analysis.Additionally, as the sterile lot number was not available, product history record (phr) reviews could not be performed.Given the limited information provided, the reported event ¿cardiac tamponade¿ and ¿pericardial effusion¿ could not be confirmed and the exact root cause could not be determined.According to the instructions for use (ifu), procedures requiring biopsy forceps should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure and are listed on the ifu.Possible complications include but are not limited to; hematoma at the puncture site, infection, perforation of the vessel wall or the myocardium, vessel trauma, embolism, and death.Cardiac tamponade can result from a pericardial effusion and is a serious medical condition in which blood or fluids fill the space between the sac that encases the heart and the heart muscle.This places extreme pressure on your heart.The pressure prevents the heart's ventricles from expanding fully and keeps your heart from functioning properly.This requires urgent drainage of the fluid, as was done in this case (pericardiocentesis).Vessel characteristics and procedural/handling factors may have contributed to the reported event.Without a lot number to conduct a phr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: BIOPSY FORCEPS 5.5F STD 104CM
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12382589
• MDR Text Key: 268654874
• Report Number: 9616099-2021-04818
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• PMA/PMN Number: K933235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 504300
• Device Catalogue Number: 504300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035¿ UNKNOWN GUIDEWIRE; 5F UNKNOWN PIGTAIL CATHETER; 5F UNKNOWN SHEATH; 6F 100CM MP UNKNOWN GUIDE CATH; HEPARIN; VERAPAMIL 2.5MG INTRA-ARTERIAL; 0.035¿ UNKNOWN GUIDEWIRE; 5F UNKNOWN PIGTAIL CATHETER; 5F UNKNOWN SHEATH; 6F 100CM MP UNKNOWN GUIDE CATH; HEPARIN; VERAPAMIL 2.5MG INTRA-ARTERIAL