MAUDE Adverse Event Report: CORDIS CORPORATION BF BIPAL 7F 50CM 2.2MM JAW; CARDIOLOGY WIRES & METALS (DWE)

Model Number 502402B

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

As reported by the customer, during removal of a bipal biopsy forceps, resistance was felt and the shaft separated.Another bipal was opened and there was difficulty removing device from packaging as well, however it was removed without damage.The physician completed the procedure with the second bipal.There was no patient injury.The intended procedure was a endomyocardial biopsy.For the procedure, a 7f biopsy forceps package was opened.When removing the bipal biopsy forceps from the packaging, resistance was felt.The physician continued to remove device and the shaft fractured/separated.This occurred prior to use on the patient.The physician then opened another bipal biopsy forceps from the same lot to use in the procedure.However, there was difficulty removing this product as well.The physician broke into the packaging in order to remove the device without damages.No kinks/bends were noted to either devices prior to removing them from the packaging.There were no damages or anomalies noted to the packaging prior to use.The second bipal was used successfully on the patient for an endomyocardial biopsy procedure.There was no patient injury.The device were discarded and are not available to be returned.

Manufacturer Narrative

The device was discarded, therefore, it is not available to be returned for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.Please note that the gender of the patient is unknown.

Manufacturer Narrative

Complaint conclusion: during removal of a bipal biopsy forceps, resistance was felt and the shaft separated.Another bipal was opened and there was difficulty removing device from packaging as well, however it was removed without damage.The physician completed the procedure with the second bipal.There was no reported patient injury.The intended procedure was an endomyocardial biopsy.When removing the bipal biopsy forceps from the packaging, resistance was felt.The physician continued to remove device and the shaft fractured/separated prior to use on the patient.The physician then opened another bipal biopsy forceps from the same lot to use in the procedure.However, there was difficulty removing this product as well.The physician broke into the packaging in order to remove the device without damages.No kinks/bends were noted to either device prior to removing them from the packaging.There were no damages or anomalies noted to the packaging prior to use.The devices were discarded and are not available to be returned.A dhr review of the job (b)(4) was performed as requested.No anomalies were found and the lot was assembled and packaged to all cordis specifications and the pouch seal test passed.With the information available and without return of the product for it is not possible to draw a clinical conclusion between the device and the reported event.However, procedural factors may have contributed to the reported event.Based on the lack of information and the inability to assign or determine a root cause no corrective actions will be taken at this time.

• Brand Name: BF BIPAL 7F 50CM 2.2MM JAW
• Type of Device: CARDIOLOGY WIRES & METALS (DWE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863133880
• MDR Report Key: 4209420
• MDR Text Key: 5043782
• Report Number: 1016427-2014-00113
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 502402B
• Device Catalogue Number: 502402B
• Device Lot Number: N0614316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANOTHER BIPAL BIOPSY FORCEPS, SAME LOT