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

Catalog Number	CQ5064
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one conquest pta dilatation catheter was received for evaluation.During visual analysis, fiber disturbance and material frayed was observed to the distal end of balloon.No other anomalies were noted.On functional testing, an in-house presto inflation device was used to inflate the balloon and water was noted to be leaking from the distal tip of the balloon.Further, the balloon fibers where stripped and under microscopic examination, a longitudinal rupture was noted to the balloon.No other functional testing performed.One photo was provided and reviewed.The photo shows a balloon catheter connected with an inflation device where blood residues noted on the balloon and table.A balloon rupture could not be observed due to the condition of photo.No other anomalies were identified.One video was provided and reviewed.In the video, an unknown inflation device is noted to be connected with the inflation luer of the catheter, but the balloon is not visible in the video.So, the evidence of balloon rupture could not be observed.No other anomalies were identified.Hence, no significant evidence of balloon rupture could be observed from the submitted photo and video.Based on the submitted photo and video, there is no significant evidence of balloon rupture but a longitudinal rupture was noted on the balloon under microscopic evaluation in the functional testing.Further, on visual analysis of returned catheter, fiber disturbance and material frayed could be observed.Therefore, the investigation is confirmed for the reported balloon rupture and identified fiber disturbance & material frayed.A definitive root cause for the reported balloon rupture and identified fiber disturbence, material frayed 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: 09/2025) 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 during an angioplasty procedure in the right upper limb, the pta balloon allegedly ruptured at 26 atm.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: CONQUEST
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18892540
• Report Number: 2020394-2024-00342
• Device Sequence Number: 18006983
• Product Code: DQY
• UDI-Device Identifier: 00801741062872
• UDI-Public: (01)00801741062872
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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: CQ5064
• Device Lot Number: REGX3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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