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

Model Number	502402B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the 7f bipal 50cm 2.2mm jaw was twisted to 90°.The procedure was lengthened and another device was used to complete the procedure.There were no patient injuries.The kink occurred during the procedure.The product was not kinked when the packaged was opened; it did not kink while the device was being removed from it package.There was no attempt to "shape" or "re-shape" the shaft or the tip.The device was removed from the tray in a horizontal motion.It's unknown where the 90° twist took place on the device.A 6f sheath was used during the procedure.After the device was evaluated, the link within the cutter assembly had fractured and caused the jaws to not function properly.The product was returned for analysis.It was identified that the link within the cutter assembly had broken and caused the jaws to not function properly.It is highly unlikely that this fracture is due to norman nobles manufacturing/assembling process because all assembled bipals are subject to a functional test at norman noble before packaging.Had the link previously been broken, or had it broken as a result of the functional test norman noble would have noticed and scrapped the part internally.It is unlikely that the part failed as a result of norman noble processing.The device history record for cordis lot n1015309 was pulled, along with subsequent referenced lots.Within the review, no lots were found to have a hold for quality review record, deviations, or abnormal levels of scrap.The reported ¿jaws kinked/bent - in patient¿ and ¿coiled shaft fractured¿ were confirmed through analysis of the returned device.The exact cause of the fractured condition could not be determined during analysis.Based on the information available for review, procedural/handling factors may have contributed to the issue reported.As stated in the instructions for use (ifu) as a precaution, ¿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 ifu also states, ¿a spring in the handle keeps the cutting jaws closed.The jaws are opened by moving the double rings away from the thumb ring.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.
Event or Problem Description
It was reported that the 7f bipal 50cm 2.2mm jaw was twisted to 90°.The procedure was lengthened and another device was used to complete the procedure.There were no patient injuries.The kink occurred during the procedure.The product was not kinked when the packaged was opened; it did not kink while the device was being removed from it package.There was no attempt to "shape" or "re-shape" the shaft or the tip.The device was removed from the tray in a horizontal motion.It's unknown where the 90° twist took place on the device.A 6f sheath was used during the procedure.After the device was evaluated, the link within the cutter assembly had fractured and caused the jaws to not function properly.

• Brand Name: BF BIPAL 7F 50CM 2.2MM JAW
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CORDIS CORPORATION; p.o. box 025700; miami FL 33152
• MDR Report Key: 6339023
• Report Number: 1016427-2017-00181
• Device Sequence Number: 19074721
• 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
• Report Date (Section B): 02/17/2017

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: 09/30/2018
• Device Model Number: 502402B
• Device Catalogue Number: 502402B
• Device Lot Number: N1015309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Distributor Facility Aware Date: 02/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1