MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD X-FORCE BALLOON DILATION CATHETER; X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER

Model Number	998606
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2020
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 folder on the dilation catheter was missing after opening the product during the procedure.As a result, the balloon couldn't be restored when the first expansion failed and a second expansion was required.It was later clarified via email on 2 june 2020 from ibc representative, that the user was referring to the refolding tool that was missing from the package.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.The potential root cause could be due to supplier error at future matrix international.As no sample was returned it cannot be determined if the device failed specification or if there is a relationship with the reported event.As the device can be used for monitoring of pressure as well as ureteral dilation , it cannot be determined based on the event, that the device was used for treatment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not completed as the reported event would not likely be caused by the user.
Event or Problem Description
It was reported that the folder on the dilation catheter was missing after opening the product during the procedure.As a result, the balloon couldn't be restored when the first expansion failed and a second expansion was required.It was later clarified via email on 2 june 2020 from ibc representative, that the user was referring to the refolding tool that was missing from the package.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: X-FORCE U30 URETEROSCOPIC BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10135543
• Report Number: 1018233-2020-03712
• Device Sequence Number: 2051010
• Product Code: EZN
• UDI-Device Identifier: 10801741052719
• UDI-Public: (01)10801741052719
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050875
• 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): 09/04/2020

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: 06/30/2021
• Device Model Number: 998606
• Device Catalogue Number: 998606
• Device Lot Number: BMCZFM21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1