MAUDE Adverse Event Report: CORDIS CORPORATION BIOPSY FORCEPS 5.5F STD 50CM; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number 504302

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

As reported, a biopsy forceps was unable to collect tissue during use.There was no reported patient injury.The procedure was completed with a new biopsy forceps.The device was removed from the tray in a horizontal motion without any excessive force.No attempt was made to shape the shaft or the tip.While attempting to use the biopsy forceps, nothing was in the forceps after biopsy.A biopsy forceps 5.5f std 50cm was received for analysis.The device was removed from the shipping package.The device was laid flat on the workbench and a severe bend/kink could be noticed at the distal end of the device.The devices are manufactured without pre-existing bends or kinks.The device was actuated and the jaws did not open and/or close.The distal end of the device was observed under magnification.Dried fluid was observed on the clevis body and links.The distal end of the device was soaked in hydrogen peroxide for 15 minutes.After soaking, an attempt was made to actuate (open and close) the device.When actuated, the device was still not responding.After opening the outer jacket and being able to look at the actuator wire closely, it was noticed that the wire was no longer attached to the clevis body, causing the device to not function as designed.Discoloration at the distal end of the actuator wire shows that the wire has been brazed to the clevis body.A product history record (phr) review of lot 70119266 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿biopsy forceps (system)- damaged - in patient¿ was confirmed since the actuator wire wasn¿t attached to the clevis body of the forceps and a severe bend/kink was noticed at the distal end of the device.Nevertheless, the cause of the unit¿s condition as received, could not be conclusively determined.Procedural/handling factors may have contributed to this type of event.According to the instructions for use (ifu), although not intended as a mitigation, ¿do not use if the inner package is open or damaged.Consider the use of systemic heparinization.If strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the forceps.¿ the recommended procedure states, ¿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.Flush the sheath introducer continuously with heparinized saline while slowly withdrawing the forceps.Note: closing of the jaws and withdrawal of the bioptome should be performed in a single motion.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of unit.No corrective or preventive actions will be taken.

Event Description

As reported, a biopsy forceps was unable to collect tissue during use.There was no reported patient injury.The procedure was completed with a new biopsy forceps.The device was removed from the tray in a horizontal motion without any excessive force.No attempt was made to shape the shaft or the tip.While attempting to use the biopsy forceps, nothing was in the forceps after biopsy.During the product evaluation, it was noticed that the wire was no longer attached to the clevis body, causing the device to not function as designed.In addition, a severe bend/kink could be noticed at the distal end of the device.

• Brand Name: BIOPSY FORCEPS 5.5F STD 50CM
• 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9675966
• MDR Text Key: 191168198
• Report Number: 1016427-2020-03798
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K933235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 504302
• Device Catalogue Number: 504302
• Device Lot Number: 70119266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• 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