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

Catalog Number	CQ75124
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
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 pta dilatation catheter was returned for evaluation.Frayed fiber and fiber disturbance were observed on the returned balloon during the visual evaluation.On the functional testing, the balloon was inflated with an in-house presto inflation device.At inflation, the balloon leaks from the distal end.Further, the balloon fibers are stripped and, under microscopic observations, longitudinal rupture was observed.No other functional testing was performed.Also, one photo review was reviewed.In the photo, the balloon appeared to be bloody and partially inflated in condition.Fiber disturbance was observed in the middle portion of the balloon around its waist, making the balloon appeared to be deformed in middle portion.No objective evidence balloon rupture could can be observed in the submitted photo.As the returned catheter shows the evidence of frayed fiber and fiber disturbance was observed during the visual evaluation and the submitted photo shows the same anomalies of fiber issue and under microscopic observations, a longitudinal balloon rupture was confirmed.Hence, the investigation was confirmed for the reported balloon rupture and identified frayed fiber and fiber disturbance.A definitive root cause for the reported balloon rupture and identified frayed fiber and fiber disturbance 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: 05/2026) 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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had popped.The procedure was completed using another balloon.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 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: 19031752
• Report Number: 2020394-2024-00433
• Device Sequence Number: 18172859
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/28/2024

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: CQ75124
• Device Lot Number: REHT3681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/03/2024
• 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 Age: 64 YR
• Patient Sex: Unknown