MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO; PTA BALLOON DILATATION CATHETER

Catalog Number	DR4084
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2026).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 prior to an angioplasty procedure, the plastic cover on the pta balloon allegedly would not come off the balloon.It was further reported that the tech tried to remove the little cover and it was stuck on the balloon.Furthermore, when they tried to remove it the balloon allegedly broke free from the catheter.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one dorado pta dilatation catheter with stylet and balloon protector covered was received for evaluation.During visual analysis a catheter shaft kink near to strain relief and kink in the inflation lumen near to distal tip could be observed.Further complete circumferential break was noted in the glue joint point.No other anomalies were noted.Due to device condition no other functional testing was performed.In the received sample analysis could observed the balloon protector covered which was not removed during the procedure, kink in the catheter shaft and inflation lumen, break in glue joint was noted.Therefore, the investigation was confirmed for the reported difficult to remove packaging material, break and identified kink in the catheter shaft, inflation lumen issues.A definitive root cause for the reported difficult to remove packaging material, break and identified kink in the catheter shaft, inflation lumen issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 12/2026), g3, h6(device).H11: section a through f ¿ the information provided by bd represents all 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 prior to an angioplasty procedure, the plastic cover on the pta balloon allegedly would not come off the balloon.It was further reported that the tech tried to remove the little cover, and it was stuck on the balloon.Furthermore, when they tried to remove it the balloon allegedly broke free from the catheter.The procedure was completed using another device.There was no patient contact.

• Brand Name: DORADO
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19571312
• Report Number: 2020394-2024-00839
• Device Sequence Number: 8470387
• Product Code: LIT
• UDI-Device Identifier: 00801741059247
• UDI-Public: (01)00801741059247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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 Catalogue Number: DR4084
• Device Lot Number: 93ZH0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown