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

Catalog Number	CQ7584
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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 is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent an angioplasty procedure using the conquest.During the procedure, the balloon allegedly circumferential ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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 pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted the device was loaded unto an unknown brand sheath.The distal tip of the sheath was buckled.The balloon catheter was noted to have a burst near to the distal tip.No other anomalies were noted to the luers, bifurcate or glue fillets.No other functional testing due to the present burst.Three photos were provided and reviewed.The first photo shows the conquest device seen inside the transparent packaging loaded onto unknown brand sheath.The device appeared to have blood residue throughout the balloon.No other anomalies were noted to the device.The labeling details in the packaging matches with the information available in the trackwise.The second photo shows the conquest device seen inside the transparent packaging.The catheter was noted to have a burst near to proximal end of the balloon.The device is partially visible in the provided photo.The gw hub and inflation hub were seen.No other anomalies were noted.The third photo shows the conquest device, and the device is partially seen.The balloon was noted to have a blood residue throughout.The catheter burst was seen near the proximal end of the balloon.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported circumferential balloon rupture as functional testing couldn't be carried out as there was a burst in the catheter shaft, which likely impacted the balloon's ability to inflate and difficulty to assess for any rupture, but the investigation is confirmed for the identified burst container or vessel as the catheter was noted to have a burst.A definitive root cause for the reported balloon rupture and identified burst container or vessel 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.G3, h3, h6 (device, component, method, result, conclusion) 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
On (b)(6) 2025, a patient underwent an angioplasty procedure using the conquest.During the procedure, the balloon catheter allegedly ruptured circumferentially.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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 pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted the device was loaded unto an unknown brand sheath.The distal tip of the sheath was buckled.The balloon catheter was noted to have a burst near to the distal tip.No other anomalies were noted to the luers, bifurcate or glue fillets.No other functional testing due to the present burst.Three photos were provided and reviewed.The first photo shows the conquest device seen inside the transparent packaging loaded onto unknown brand sheath.The device appeared to have blood residue throughout the balloon.No other anomalies were noted to the device.The labeling details in the packaging matches with the information available in the trackwise.The second photo shows the conquest device seen inside the transparent packaging.The catheter was noted to have a burst near to proximal end of the balloon.The device is partially visible in the provided photo.The gw hub and inflation hub were seen.No other anomalies were noted.The third photo shows the conquest device, and the device is partially seen.The balloon was noted to have a blood residue throughout.The catheter burst was seen near the proximal end of the balloon.No other anomalies were noted.Therefore, the investigation is inconclusive for the reported circumferential balloon rupture as functional testing couldn't be carried out as there was a burst in the catheter shaft, which likely impacted the balloon's ability to inflate and difficulty to assess for any rupture, but the investigation is confirmed for the identified burst container or vessel as the catheter was noted to have a burst.A definitive root cause for the reported balloon rupture and identified burst container or vessel 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.G2, g3 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
On (b)(6) 2025, a patient underwent an angioplasty procedure using the conquest.During the procedure, the balloon catheter allegedly ruptured circumferentially.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 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: 21982361
• Report Number: 2020394-2025-00685
• Device Sequence Number: 4478317
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114(17)270531(10)REJT3421
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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: CQ7584
• Device Lot Number: REJT3421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 12/18/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/31/2025; 12/28/2025
• 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