MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40; PTA BALLOON DILATATION CATHETER

Catalog Number	CQF7588
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4.(expiration date: 10/2026).H11: section a: through f: the information provide 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 of the fistula via the distal cephalic vein, the pta balloon allegedly ruptured at 20 atm.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure of the fistula via the distal cephalic vein, the pta balloon allegedly ruptured at 20 atm.There was no reported patient injury.
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 conquest 40 pta dilatation catheter was returned to evaluation.On the visual evaluation compound rupture and frayed fibers was noted on the returned balloon.No functional testing performed due the nature of the condition of device.Four images were reviewed.The first image shows a stent within a second stent with contrast flowing through the treated section with resolution of the extravasation.The second image is of the stenotic cephalic vein with a catheter in the vein.The second image shows a stent within the vein that has been deployed and a balloon catheter partially inflated with contrast extravasation indicating rupture of the treated vein.The fourth image is an x-ray of the dilated stent within the vein.No contrast is noted in the soft tissue.As the submitted radiographic image confirms the evidence of balloon rupture and in sample analysis the visual evaluation confirmed the evidence compound balloon rupture and material frayed.Hence the investigation was confirmed for the reported balloon rupture and identified material frayed.A definitive root cause for the reported balloon rupture and identified material frayed 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: 10/2026), h6 (device).H11: h6 (method, result, conclusion).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.
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 conquest 40 device was returned for evaluation.A rupture and frayed fibers were noted to the balloon.The balloon was stripped, and a longitudinal rupture was noted to the balloon.No further functional testing was performed.Four images were reviewed.The first image showed a stent within a second stent with contrast flowing through the treated section with resolution of the extravasation.The second image was of the stenotic cephalic vein with a catheter in the vein.The third image showed a stent within the vein that has been deployed and a balloon catheter partially inflated with contrast extravasation indicating rupture of the treated vein.The fourth image was an xray of the dilated stent within the vein.No contrast was noted in the soft tissue.Therefore, the investigation is confirmed for the reported balloon rupture as a longitudinal rupture was noted to the balloon.The investigation is also confirmed for the identified material frayed as frayed fibers were noted to the balloon.A definitive root cause for the reported balloon rupture and identified material frayed 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.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 fistula via distal cephalic vein, the pta balloon allegedly ruptured at 20 atm.There was no reported patient injury.

• Brand Name: CONQUEST 40
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 18984432
• Report Number: 2020394-2024-00396
• Device Sequence Number: 12813063
• Product Code: DQY
• UDI-Device Identifier: 00801741060571
• UDI-Public: (01)00801741060571(17)261031(10)REHY2863
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• 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,Followup
• Report Date (Section B): 10/18/2024

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: CQF7588
• Device Lot Number: REHY2863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 10/18/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 07/10/2024; 11/11/2024
• 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