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

Catalog Number 995081

Device Problem Material Fragmentation (1261)

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

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported that the x-force n30 nephrostomy balloon dilation catheter was damaged prior to use and unusable.

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 bard 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 bard.

Event Description

It was reported that the x-force n30 nephrostomy balloon dilation catheter was damaged prior to use and unusable.

Manufacturer Narrative

The reported event is unconfirmed as the product meets specifications.Visual evaluation noted the sample was received in a closed ziploc bag identified with a biohazard label and sterilized by eo label; the bag was handwritten.Inside of the bag there was the balloon catheter with the balloon guard still in place.The balloon hub of the catheter reads "8 x 15 cm" and "30 atm"; the wire hub reads "0.038 (0.97mm) wire".The sample was evaluated in the bio testing lab, first performing a visual inspection of the device and no visible anomalies were identified.In this visual inspection it was noticed that the balloon had the guard still in place, and when the guard was removed it was observed that the balloon was never inflated since it was still fully folded.Functional evaluation noted upon completion of the visual inspection, a functional testing was performed introducing a 0.038" guidewire through the wire hub; the guide wire was introduced without resistance through all the catheter inner lumen hub.Then using the balloon hub the catheter was filled with distilled water using an inflation device.The balloon was inflated and then it was pressurized up to 30 atm without shown leaks or irregularities.Afterwards, the balloon ws deflated applying vacuum in the inflation device and it was deflated without problems.Based on the results of the sample evaluation this complaint is unconfirmed since the balloon was inflated and deflated without complications and no irregularities were observed.No root cause could be found because the reported event was unconfirmed.The lot number is unknown; therefore, the device history record could not be reviewed.The labelling review is not required as the reported event is unconfirmed.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: 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: 17894931
• MDR Text Key: 325388387
• Report Number: 1018233-2023-07264
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 995081
• Device Lot Number: BMEZFM14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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