MAUDE Adverse Event Report: CORDIS CORPORATION BF BIPAL 7F 50CM 2.2MM JAW; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	502402B
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During a myocardia biopsy performed as part of a post-transplant rejection routine surveillance exam, it was reported that the bipal 7f 50cm 2.2mm jaw clamp stayed locked in a closed position into the right ventricle, blocking the clamp to be removed.There was no patient injury.
Additional Manufacturer Narrative
During a myocardia biopsy performed as part of a post-transplant rejection routine surveillance exam, it was reported that the bipal 7f 50cm 2.2mm jaw clamp stayed locked in a closed position into the right ventricle, blocking the clamp to be removed.There was no patient injury.The device was not returned for analysis.A device history record (dhr) review of lot n1016315 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿jaws open/close difficulty - in patient¿ and ¿biopsy forceps withdrawal difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause of the burst could not be determined.Based on the limited information available for review, procedural/handling factors may have contributed to the issue reported as damage to the biopsy forceps can impair the opening/closing function of the jaws.As standard use of the device, it is recommended to check if the jaws of the biopsy forceps are opening and closing properly prior to use in the patient.As cautioned by the instructions for use, which is not intended as a mitigation, ¿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.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.
Additional Manufacturer Narrative
This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
During a myocardial biopsy performed as part of a post-transplant rejection routine surveillance exam, it was reported that the bipal 7f 50cm 2.2mm jaw clamp stayed locked in a closed position into the right ventricle, preventing the clamp from being removed.There was no patient injury.The device was returned for analysis.The entire bipal was inspected, with a focus on the handle, biopsy forceps, wire, and connection joints.Nothing abnormal was noted with the connections or parts.Additionally, all bipal devices are subjected to a functional test once they are assembled, before packaging.It is unlikely that the part failed as a result of processing.The events reported by the customer as ¿biopsy forceps (system) - withdrawal difficulty¿ and jaws (biopsy forceps)- open/close difficulty - in patient¿ were not confirmed since the returned unit was inspected and nothing abnormal was noted with the connections or parts; also the phr was reviewed and there were no abnormalities identified with the lot processing.Neither phr review nor the product analysis suggests the reported failures could be related to the bipal manufacturing process.According to the instructions for use, which is not intended as a mitigation ¿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.¿ neither the phr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: BF BIPAL 7F 50CM 2.2MM JAW
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6827732
• Report Number: 1016427-2017-00564
• Device Sequence Number: 1196986
• Product Code: DWE
• UDI-Device Identifier: 20705032054956
• UDI-Public: 20705032054956
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K933235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 502402B
• Device Catalogue Number: 502402B
• Device Lot Number: N1016315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Distributor Facility Aware Date: 08/03/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 09/08/2017; 01/09/2018; 04/11/2018
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 09/14/2017; 01/11/2018; 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 83