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

Model Number 996081

Device Problem Accessory Incompatible (1004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that the survey respondent stated no to the question, were you able to use the refolding tool to refold the balloon dilation catheter for reinsertion.The physician was not able to use the refolding tool to refold the 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile because difficult to maneuver.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be user lacks appropriate training on technique, user lacks dexterity necessary, user does not use device as indicated.The device was not returned for evaluation.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: "using the refolding tool the balloon catheter is supplied with a refolding tool.This aids in preparing the balloon for another insertion.During the procedure.To use: 1.Manually compress the balloon.2.Position the refolding tool at one end.3.Twist the refolding tool counter clockwise and push down on the balloon until it goes the entire length of the balloon.4.Once the balloon is folded, remove the refolding tool and proceed with the procedure." h11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that in an online survey the physician stated no to the question, were you able to use the refolding tool to refold the balloon dilation catheter for reinsertion.The physician was not able to use the refolding tool to refold the 996081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, w/ inflation device, sterile because difficult to maneuver.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17019038
• MDR Text Key: 316107558
• Report Number: 1018233-2023-03845
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10801741127653
• UDI-Public: (01)10801741127653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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
• Device Operator: Health Professional
• Device Model Number: 996081
• Device Catalogue Number: 996081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other