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

Catalog Number	CQF7584
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was allegedly ruptured upon inflation at 20 atm.It was further reported that when the balloon was pulled, it became dislodged from the catheter shaft.Reportedly, the dislodged portion was able to be grabbed with forceps and extract from the patient and there was a difficulty in retracting the balloon thru the sheath.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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: d2b (dqy; lit).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
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 40 pta dilatation catheter returned for evaluation.During visual evaluation, no kinks noted to the catheter shaft, no anomalies to the luers and bifurcate.The balloon was noted to have a circumferential rupture near the proximal end of the balloon.Balloon fibers were coming loose from the proximal end and cinching the end of the rupture.In addition, the proximal end of the balloon remained at the proximal glue joint of the exposed inner guidewire lumen.Marker bands were noted to be present but not seated correctly on the inner guidewire lumen.In addition, the glue bullet was not seated on the outer catheter.The distal tip of the inner guidewire lumen detached along with the balloon.No functional testing was performed due to the nature of the complaint.Therefore, the investigation is confirmed for the reported balloon rupture as a complete circumferential rupture was noted to the balloon.Also, the investigation is confirmed for the identified detachment as the distal tip of inner guidewire lumen along with the balloon is completely detached.The investigation is confirmed for the reported sheath removal difficulty as the balloon was noted to be cinched, which could cause the removal difficulties.However, the investigation is unconfirmed for the reported break as no break was noted on the returned device.A definitive root cause for the reported balloon rupture, break, difficult to remove and identified detachment 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.D2b (dqy; lit), g3, 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
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured upon inflation at 20 atm.It was further reported that when the balloon was pulled, it became dislodged partially from the catheter shaft.Reportedly, the dislodged portion was able to be grabbed with forceps and extract from the patient and there was a difficulty in retracting the balloon thru the sheath.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: 21665723
• Report Number: 2020394-2025-00371
• Device Sequence Number: 18048642
• Product Code: DQY
• UDI-Device Identifier: 00801741060557
• UDI-Public: (01)00801741060557(17)270131(10)REJP2142
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: CQF7584
• Device Lot Number: REJP2142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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