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

Catalog Number	995081
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the x-force n30 nephrostomy balloon dilation catheter was damaged prior to use and unusable.
Additional 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 or Problem Description
It was reported that the x-force n30 nephrostomy balloon dilation catheter was damaged prior to use and unusable.
Additional 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
• Common Device Name: 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
• Report Number: 1018233-2023-07264
• Device Sequence Number: 17894225
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• 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: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown