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

Catalog Number	CQ75124
Medical Device Problem Codes	Leak/Splash (1354); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.One photo was received and reviewed.The photo shows a health professional holding the catheter with a balloon in an inflated condition and unraveled fibers could be observed in the distal end of balloon.No evidence of leak was observed in the provided photo.No other anomalies were found in the photo.One video was received and reviewed.In the provided video balloon attached with the catheter was inflated by the healthcare professional from which was water leaked in between the distal tip and balloon.Source of leak could not be determined from the provided video.No other anomalies were noted.No significant evidence of leak noted on the submitted photo.However, based on the submitted video evidence of leak could be observed and the source of leak could not be noted.Hence the investigation confirmed for the reported leak and the identified fiber unraveled as it was noted on the submitted photo.A definitive root cause for the reported leak issue 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.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 : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure in the right upper limb, the pta balloon allegedly had air leakage.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 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: 18938871
• Report Number: 2020394-2024-00365
• Device Sequence Number: 6893345
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251
• 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
• Report Date (Section B): 03/18/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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