MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® BALLOON DILATION CATHETER; BARD X-FORCE

Model Number	998006
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that there was no pump.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that there was no pump.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿1.Preparation of the inflation device make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.In this position, you can freely pull the piston back for aspiration, or push it forward for injection.To lock the piston in position, slide the lever right to the straight up position.1) prepare a solution of contrast medium and normal saline in a bowl.Check balloon catheter and contrast medium instructions for specific contrast mixture recommendations.2) orient the tubing downward into the contrast medium.3) push the release lever left and aspirate enough solution to fill the syringe.2.Preparation of the catheter 1) remove the protective sheath from the balloon.* slide refolding tool to proximal end of catheter.2) attach the inflation device to the extension tube for balloon lumen.3) open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter.4) close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach the balloon catheter." correction: device identification.
Event or Problem Description
It was reported that there was no pump.
Event or Problem Description
It was reported that there was no pump.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿[directions for use] 1.Preparation of the inflation device.Make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.In this position, you can freely pull the piston back for aspiration, or push it forward for injection.To lock the piston in position, slide the lever right to the straight up position.1) prepare a solution of contrast medium and normal saline in a bowl.Check balloon catheter and contrast medium instructions for specific contrast mixture recommendations.2) orient the tubing downward into the contrast medium.3) push the release lever left and aspirate enough solution to fill the syringe.2.Preparation of the catheter.1) remove the protective sheath from the balloon.Slide refolding tool to proximal end of catheter.2) attach the inflation device to the extension tube for balloon lumen.3) open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter.4) close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach the balloon catheter." correction: d1, d2, d4, d10, g5, h3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BARD X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8343615
• Report Number: 1018233-2019-00840
• Device Sequence Number: 183306
• Product Code: EZN
• UDI-Device Identifier: 10801741052801
• UDI-Public: (01)10801741052801
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/24/2019

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: 06/08/2019
• Device Model Number: 998006
• Device Catalogue Number: 998606
• Device Lot Number: BMAYFM42
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 04/23/2019; 05/03/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/05/2019; 04/29/2019; 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1