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

Model Number	998606
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2020
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.The device was not returned.
Event or Problem Description
It was reported that the catheter balloon was difficult to inflate.The shaft area near the balloon allegedly was inflated.The device was not used.
Event or Problem Description
It was reported that the catheter balloon was difficult to inflate.The shaft area near the balloon allegedly was inflated.The device was not used.
Additional Manufacturer Narrative
The reported event was confirmed.A x-force balloon dilation catheter was received open without its original packaging.The catheter was visually inspected under 7-20x magnification and appeared to contain an outer shaft burst 7mm proximal to the balloon.An inflation device was used to attempt inflation but it failed due to the burst shaft.The minimum wall was measured and was found to meet minimum acceptance criteria 0.0060".According the supplier, the root cause was not able to be determined.A potential root cause could be due to "poor inflation lumen design".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: "the lumen labeled with the rated burst pressure (xx atm) is for balloon inflation do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded." 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 X-FORCE BALLOON DILATION CATHETER
• Common Device Name: URETERAL BALLOOON
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10620383
• Report Number: 1018233-2020-06311
• Device Sequence Number: 11483372
• Product Code: EZN
• UDI-Device Identifier: 10801741052719
• UDI-Public: (01)10801741052719
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• 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): 01/26/2021

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: 02/25/2022
• Device Model Number: 998606
• Device Catalogue Number: 998606
• Device Lot Number: BMDVFM18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1