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

Model Number	996101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	05/31/2019
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 balloon was used during a pcnl surgery and leakage occurred from the pump to the balloon.It was also noted that fluid could not be injected into the balloon.
Additional Manufacturer Narrative
The reported event was confirmed as use-related.The evaluation report of the returned sample, submitted by atrion medical, stated that during the functional testing, the device leaked from the clamp area and would not build pressure.The clamps were removed from the device, and it was noted that the o-ring was out of position.When the o-ring was removed and replaced with a new one, no leaking was observed and the device passed all functional testing.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿¿ 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." 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.
Event or Problem Description
It was reported that the balloon was used during a pcnl surgery and leakage occurred from the pump to the balloon.It was also noted that fluid could not be injected into the balloon.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY 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: 8708256
• Report Number: 1018233-2019-03178
• Device Sequence Number: 16762307
• Product Code: LJE
• UDI-Device Identifier: 10801741127660
• UDI-Public: (01)10801741127660
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063632
• 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
• Report Date (Section B): 09/13/2019

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 Model Number: 996101
• Device Catalogue Number: 996101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1