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

Catalog Number	CQ5062
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025) 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 for stenotic lesion, the pta balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure for stenotic lesion, rupture of the pta balloon head had allegedly occurred and blood had flowed into the pressure pump when pressure was released to discover the rupture.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: b5, d4 (expiry date: 10/2025).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 pending return.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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.Fraying and bunching were noted to the distal end of the balloon.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 compound rupture was noted to the balloon.No other functional testing performed.One video was reviewed.The video shows the conquest balloon held by a health professional.Liquid is seen leaking from the distal end of the balloon.Therefore, the investigation is confirmed for the reported balloon rupture as a compound rupture was noted to the balloon under microscopic examination.The investigation is also confirmed for the identified fraying of fibers as fraying was observed to the distal end of the balloon.A definitive root cause for the reported balloon rupture and identified fraying of fibers 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: 10/2025), g3, h2, h6 (device) h11: h6 (method, result, conclusion) 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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure for stenotic lesion, rupture of the pta balloon head had allegedly occurred and blood had flowed into the pressure pump when pressure was released to discover the rupture.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.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.Fraying and bunching were noted to the distal end of the balloon.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 compound rupture was noted to the balloon.No other functional testing performed.One video was reviewed.The video shows the conquest balloon held by a health professional.Liquid is seen leaking from the distal end of the balloon.Therefore, the investigation is confirmed for the reported balloon rupture as a compound rupture was noted to the balloon under microscopic examination.The investigation is also confirmed for the identified fraying of fibers as fraying was observed to the distal end of the balloon.A definitive root cause for the reported balloon rupture and identified fraying of fibers 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), g3, h4.H11: d4 (unique identifier (udi) #).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.
Event or Problem Description
It was reported that during an angioplasty procedure for stenotic lesion, rupture of the pta balloon head had allegedly occurred and blood had flowed into the pressure pump when pressure was released to discover the rupture.The procedure was completed using another device.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: 18298178
• Report Number: 2020394-2023-01196
• Device Sequence Number: 6970781
• Product Code: DQY
• UDI-Device Identifier: 00801741062865
• UDI-Public: (01)00801741062865(11)221210(17)251031(10)REGY1033
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: CQ5062
• Device Lot Number: REGY1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2023
• Supplement Date Received by Manufacturer: 12/17/2023; 02/29/2024; 06/13/2024
• Initial Report FDA Received Date: 12/09/2023
• Supplement Report FDA Received Date: 01/12/2024; 03/08/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2022
• 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