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

Model Number	997606
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2020
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.
Event or Problem Description
It was reported that the pointer of the pump did not move when injected water into the balloon and in a review it was found that the proximal rod of the balloon catheter was damaged.Per additional information from the ibc via email (b)(6) 2020; the dilation catheter balloon closest to the tip of the catheter was damaged.
Event or Problem Description
It was reported that the pointer of the pump did not move when injected water into the balloon and in a review it was found that the proximal rod of the balloon catheter was damaged.Per additional information from the ibc via email 26may2020, the dilation catheter balloon closest to the tip of the catheter was damaged.
Additional Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause could be due to contact with a stone.As no sample was returned, it cannot be determined if the device met specifications or its relationship with reported event.Also based on the ifu, this product "can be used for monitoring of pressure or the infusion of medication and/or contrast medium" and "is recommended for use in the dilation of the urinary tract", it cannot be determined based on the event if the device was used for treatment of diagnosis.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: ¿catheter insertion 1.Introduce the catheter carefully over a 0.038¿ (.97mm) guidewire and place it in the area that needs to be dilated.Use the radiopaque markers to aid in proper positioning.Note: dilation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment or direct vision.Inflating the balloon catheter 1.Fill the inflation device (eagle¿ inflation device) with sterile diluted contrast medium.2.Attach the inflation device to the balloon lumen.3.Inflate the balloon note: do not use air or any gaseous substances as a balloon inflation medium always use sterile liquid media.Note: the use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the rated burst pressure of the balloon is not exceeded.Caution: if loss of pressure in the balloon occurs or the balloon ruptures, immediately stop the procedure, deflate the balloon and remove carefully.Do not attempt to re-inflate the balloon.If after inspection it is noted pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible.Warning: do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.Deflating the balloon catheter deflate the balloon using an inflation device.Since deflation times vary based on balloon sizes and shaft lengths, check fluoroscopically to confirm deflation before attempting to withdraw.1.Attach the inflation device (eagle¿ inflation device) to the balloon catheter and remove the solution from the balloon by pulling back on the inflation device.2.Remove the inflation device from the balloon catheter.This will allow ambient pressure to enter, relaxing the balloon.3.Gently withdraw the catheter.Use of a gentle counterclockwise twisting motion is recommended when removing the catheter." 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.H3 other text : the device was not a bd product.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: X-FORCE DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10125786
• Report Number: 1018233-2020-03647
• Device Sequence Number: 2420935
• Product Code: EZN
• UDI-Device Identifier: 00801741052101
• UDI-Public: (01)00801741052101
• 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): 09/03/2020

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: 04/13/2021
• Device Model Number: 997606
• Device Catalogue Number: 997606
• Device Lot Number: BMCRFM66
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1