MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO BIOPSY FORCEPS 5.5F STD 104CM; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: 5f unknown pigtail catheter, 0.035¿ unknown guidewire.This complaint was identified during a recent clinical evaluation review/literature search of this device.A copy of the publication is attached to this report.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.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem 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 cardiac tamponade after 3 biopsies were taken with a 5f, 104 cm cordis bioptome biopsy forceps via the right femoral artery.Pericardiocentesis was performed without the need for surgery and the patient had an uneventful recovery.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.
Additional Manufacturer Narrative
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 cardiac tamponade after 3 biopsies were taken with a 5f, 104cm cordis bioptome biopsy forceps via the right femoral artery.Pericardiocentesis was performed without the need for surgery and the patient had an uneventful recovery.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¿ 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 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.Additionally, 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
• Common Device Name: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 12376909
• Report Number: 9616099-2021-04812
• Device Sequence Number: 11064473
• Product Code: DWZ
• UDI-Device Identifier: 10705032056090
• UDI-Public: 10705032056090
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K933235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 504300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F 100 CM MP UNKNOWN GUIDE; 6F 100 CM MP UNKNOWN GUIDE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 32 YR