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

Catalog Number	CQF75124
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 26 atm.It was further reported that the doctor had to do a cut down to retrieve the balloon.Reportedly, there was difficulty in retracting the balloon through the introducer sheath.The current status of the patient is unharmed, procedure finished and access still open.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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
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 for evaluation.During visual evaluation, the balloon was loaded onto an unknown guidewire and the balloon was noted to be stuck onto an unknown sheath.The balloon was noted to be prolapsed with bunching at the distal and proximal end.Further, the balloon was also noted to have a circumferential rupture.The distal tip of the sheath was noted to be damaged with bucking, no other anomalies were noted.No functional testing could be performed due to the returned condition of the device.Therefore, the investigation is confirmed for the reported balloon rupture as the balloon was noted to have a circumferential rupture.Also, the investigation is confirmed for the reported difficult to remove from sheath as the balloon was returned with an unknown sheath stuck onto it and also noted to be prolapsed with bunching at the distal and proximal end.Also, the sheath was noted buckled which may cause removal difficulty.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.H10: g3.H11: d2b (dqy;lit), d4, d4 (unique identifier (udi) #), 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 26 atm.It was further reported that the doctor had to do a cut down to retrieve the balloon.Reportedly, there was difficulty in retracting the balloon through the introducer sheath.The current status of the patient is unharmed, procedure finished and access still open.

• 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: 21089165
• Report Number: 2020394-2025-00003
• Device Sequence Number: 8752427
• Product Code: DQY
• UDI-Device Identifier: 00801741060663
• UDI-Public: (01)00801741060663(17)270731(10)REJV1360
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• 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): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CQF75124
• Device Lot Number: REJV1360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown