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

Model Number	CQF7594
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Malfunction
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: one conquest 40 pta dilatation catheter was received for evaluation.A image was provided for evaluation.During visual evaluation, frayed fibers were noted to the balloon.No kinks were noted to the catheter shaft and no anomalies to the luers, bifurcate or glue fillets.During functional evaluation, an in-house presto inflation device was used to inflate the balloon and water was noted leaking from the balloon.The balloon fibers were stripped and under microscopic examination, a pinhole rupture was noted to the balloon.No other functional testing was performed.One image was provided and reviewed.A zoomed in image at an unknown location showed a wire and catheter within a vessel.An angioplasty balloon appeared at least partially inflated.Numerous arrows from imaging software were pointing towards an area that might have represented contrast extravasation outside the balloon but inside vessel, possibly representing balloon rupture.The provided media was not of sufficient quality to definitely confirm a rupture.Therefore, the investigation is confirmed for the reported balloon rupture as a pinhole rupture was noted to the balloon under microscopic examination of the returned device.The investigation is also confirmed for the identified frayed fibers as frayed fibers were noted on the balloon during visual evaluation of the returned device.A definitive root cause for the reported pinhole balloon rupture and identified frayed fibers could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Expiry date: 05/2025.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured within nominal burst pressure.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: 16426291
• Report Number: 2020394-2023-00105
• Device Sequence Number: 19472107
• Product Code: DQY
• UDI-Device Identifier: 00801741060601
• UDI-Public: (01)00801741060601
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 01/31/2023

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 Model Number: CQF7594
• Device Catalogue Number: CQF7594
• Device Lot Number: REGT5725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/23/2023
• 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