MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® EAGLE® INFLATION DEVICE; EAGLE INFLATION DEVICE

Model Number	998506
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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 the dilatation catheter was found to have a damaged balloon upon removal of the catheter.The user noted the meter did not go up as usual when the expansion fluid was injected into the device, and thus removed the catheter to find a burst balloon.
Event or Problem Description
It was reported that the dilatation catheter was found to have a damaged balloon upon removal of the catheter.The user noted the meter did not go up as usual when the expansion fluid was injected into the device, and thus removed the catheter to find a burst balloon.
Additional Manufacturer Narrative
The reported event was confirmed, as use-related.Evaluation report of the returned sample, submitted by atrion medical, stated that during functional testing, the device would not draw water and could hear air being pulled in.The device leaked from the o-ring/clamp area and would not build pressure, because the o-ring was dislocated and blown out of its assembled position.When the o-ring was removed and replaced with a new one, the device passed the pressure leak, pressure decay, and vacuum capability tests with no leaking observed.Due to the gauge being off zero as received in, the device failed the gauge accuracy portion of the functional test.Atrion medical concluded that the device gauge needle being off zero and the dislocated o-ring were conditions found as a result of over-pressurization of the device.Since the device passed full functional testing prior to shipment from atrion's facility and again when a new o-ring was inserted into the device, the root-cause was determined to be user misuse.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: ¿indications: the inflation device is recommended for use while performing urological balloon dilation procedures to inflate the balloon, sustain pressure, monitor pressure within the balloon, and deflate the balloon.Contraindication: none.Warnings: ¿ use only liquid inflation media.Do not inflate with air.¿ always follow the manufacturer¿s directions accompanying the balloon dilation catheter for instructions for use, maximum balloon inflation pressure, precautions, and warnings for that device.¿ this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable regulations.Precaution: ¿ before use, inspect the device to verify that no damage has occurred during shipping and handling.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Instructions for use: preparation: make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.Unlock the piston by pushing the lock lever left.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 small sterile bowl or in the well provided with the package.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.4.Hold the device upright to purge the air from the syringe and connecting tube.Tap the syringe lightly, if necessary, to remove all the air bubbles and fill the connecting tube completely.5.Inspect the syringe and tubing to ensure that the device has been completely purged.6.Adjust the syringe volume to 3 to 4cc.If more contrast solution is needed, submerge the syringe tip into the basin of solution and aspirate.Attaching the inflation device to the balloon dilation catheter: 1.Prepare and test the balloon dilation catheter according to the manufacturer¿s directions for use.2.If a separate syringe was used to prepare the balloon catheter, remove it.Create a fluid-fluid connection between the balloon and the connecting tube (male rotating adapter) of the inflation device by placing a drop of contrast solution from the syringe into each hub.3.Hand tighten the hubs securely.Balloon inflation and deflation: 1.Release the lock lever and allow the piston to move forward into neutral position (0 atm).2.To inflate the balloon, engage the lock lever, turn the palm grip on the piston clockwise slowly until the desired inflation pressure is reached.The lock lever maintains the increasing pressure.3.To deflate the balloon, push the lock lever left, releasing the piston, and pull back.Slide the lock lever back to lock, if desired." 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.

• Brand Name: BARD® EAGLE® INFLATION DEVICE
• Common Device Name: EAGLE INFLATION DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9403462
• Report Number: 1018233-2019-07669
• Device Sequence Number: 19502329
• Product Code: KOE
• UDI-Device Identifier: 10801741052689
• UDI-Public: (01)10801741052689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 03/31/2021
• Device Model Number: 998506
• Device Catalogue Number: 325110
• Device Lot Number: BMCRAT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1