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

Catalog Number	CQ5064
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, when the pressure was pumped to 8 atm during repeat dilatation, pressure pump abnormality was noticed and blood was allegedly seen on gentle retraction.It was further reported that the pta balloon allegedly could not be fully retracted.Furthermore, upon removal of the balloon from the sheath, the balloon was allegedly found to be broken.The procedure was completed by using another device.There was no reported patient injury.
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 not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4.(expiration date: 10/2025).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.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One video was reviewed.The video shows the conquest balloon.Liquid is seen streaming from the proximal end of the balloon during an attempt to inflate it.Therefore, the investigation is confirmed for the reported balloon rupture as the balloon was seen leaking during inflation.However, the investigation is inconclusive for the reported removal difficulty as no objective evidence was provided.A definitive root cause for the reported balloon rupture and removal difficulty 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.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 during an angioplasty procedure, when the pressure was pumped to 8 atm during repeat dilatation, pressure pump abnormality was noticed and blood was allegedly seen on gentle retraction and the pta balloon allegedly could not be fully retracted.Reportedly, the balloon allegedly cracked and leaked.The procedure was completed by 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 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: 18976712
• Report Number: 2020394-2024-00391
• Device Sequence Number: 20408147
• 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,Followup
• Report Date (Section B): 05/15/2024

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: REGY0978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 05/26/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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