MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN BIOPSY FORCEPS; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number UNK-BIOPSYFORCEPS

Device Problem Defective Component (2292)

Patient Problem Embolism/Embolus (4438)

Event Date 01/01/1980

Event Type  Injury  

Manufacturer Narrative

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.While using the biopsy forceps, the physician indicated he had the inability to obtain an adequate tissue sample.They failed to grasp the tissue 1-2 times.An embolism was also noted when using the device.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.Without the return of the device for analysis and based on the information provided, the reported ¿embolism¿ was not confirmed.Procedural and or handling factors such the user¿s interaction with the device may have led to the reported event.Additionally, no procedural images or films have been made available.According to the instructions for use ¿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.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.¿ additionally, refer to the ¿description¿ section for aid in selecting the size of the sheath introducer and biopsy forceps to be used.Using fluoroscopy, advance the forceps through the appropriate sheath introducer and into the right or left ventricle.Note: when using the 104 cm biopsy forceps, confirm the position of the sheath introducer in the ventricle prior to each biopsy to be performed.After confirming that the tip of the forceps is in the ventricle, open the jaws.Advance the open jaws to the heart wall.Close the jaws firmly to obtain a tissue specimen.Maintain sufficient pressure on the double rings to assure retention of specimen during withdrawal.Note: closing of the jaws and withdrawal of the bioptome should be performed in a single motion.Flush the sheath introducer continuously with heparinized saline while slowly withdrawing the forceps.Remove the sample from jaws.Rinse bioptome before and after each biopsy.Repeat steps 2 thru 7 until sufficient tissue volume is obtained.¿neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, while using the biopsy forceps, the physician indicated he had the inability to obtain an adequate tissue sample.They failed to grasp the tissue 1-2 times.An embolism was also noted when using the device.The device will not be returned for evaluation.

• Brand Name: UNKNOWN BIOPSY FORCEPS
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14191018
• MDR Text Key: 289951254
• Report Number: 1016427-2022-05398
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-BIOPSYFORCEPS
• Device Catalogue Number: UNK-BIOPSYFORCEPS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• 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): Other