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

Model Number	997606
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
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 balloon-catheter junction was bent and folded, through which the guide wire could not pass when the package was opened.
Event or Problem Description
It was reported that the balloon-catheter junction was bent and folded, through which the guide wire could not pass when the package was opened.
Additional Manufacturer Narrative
The reported event was confirmed as supplier related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The device was not used for diagnostic or treatment purposes, as it was not used on a patient.A potential root cause for this failure could be "lack of training".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event is unlikely to be caused by the user.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 actual/suspected device was inspected.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11212492
• Report Number: 1018233-2020-22615
• Device Sequence Number: 11315287
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 05/31/2021
• Device Model Number: 997606
• Device Catalogue Number: 997606
• Device Lot Number: BMCUFM14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other