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

Model Number	997610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2020
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 catheter balloon was exploded during surgery.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A balloon dilation catheter was returned.Sample evaluation noted 1 mm sized puncture was found on the distal cone.The puncture damage is from the outside inward.A potential root cause of this issue could be due to "contact with stone".As the balloon was found to be a punctured, there is a relationship between the device and the reported event.However as the root cause was unknown and it cannot be determined if the device met specifications.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 x-force® balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident" "extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi." 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.
Event or Problem Description
It was reported that the catheter balloon was exploded during surgery.Per additional information received via email on 24jun2020 from ibc representative, since there was no missing pieces, the air leaked out while try to inflation.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: URETHRAL BALLOON CATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10155493
• Report Number: 1018233-2020-03858
• Device Sequence Number: 2153570
• Product Code: EZN
• UDI-Device Identifier: 00801741052118
• UDI-Public: (01)00801741052118
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 11/09/2021
• Device Model Number: 997610
• Device Catalogue Number: 997610
• Device Lot Number: BMDRFM30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 05/23/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 DA