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

Catalog Number	CQF7598
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
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 40 pta dilatation catheter was received for evaluation with the balloon protector and stylet loaded onto the balloon at its distal end.During visual evaluation, stretching and bunching was observed on the catheter shaft.No anomalies were noted to the luers/bifurcate.During functional evaluation, the sample guidewire lumen was flushed.An in-house syringe was used to flush the in-house introducer sheath without any issues.The patency of the guidewire lumen was then tested using an in-house guidewire but was unsuccessful due to the condition of the device.The guidewire and sheath were removed.Then, an attempt to inflate the balloon was made and the balloon was able to be inflated after maneuvering the catheter.An attempt to deflate the balloon was unsuccessful.The balloon was cut and the glue bullet was noted to be seated correctly.No other functional testing was performed.Three photos were provided and reviewed.The first photo shows the conquest 40 balloon with the balloon protector over the distal part of the balloon.The balloon is seen deflated and bloody.The second photo shows the label of the device which matches with the information in trackwise.The third photo shows the luers of the device.No specific abnormalities can be seen.Therefore, the investigation is unconfirmed for the reported inflation issue as the balloon was able to be inflated.However, the investigation is confirmed for the identified material deformation as stretching and bunching was observed on the catheter shaft, and for the identified deflation issue as an attempt to deflate the balloon was unsuccessful.A definitive root cause for the reported inflation issue, identified material deformation and deflation 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.H10: d4 (expiry date: 06/2023) 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 failed to inflate.The procedure was completed using another device.There was no reported patient injury.
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 40 pta dilatation catheter was received for evaluation with the balloon protector and stylet loaded onto the balloon at its distal end.During visual evaluation, stretching and bunching was observed on the catheter shaft.No anomalies were noted to the luers/bifurcate.During functional evaluation, the sample guidewire lumen was flushed.An in-house syringe was used to flush the in-house introducer sheath without any issues.The patency of the guidewire lumen was then tested using an in-house guidewire but was unsuccessful due to the condition of the device.The guidewire and sheath were removed.Then, an attempt to inflate the balloon was made and the balloon was able to be inflated after maneuvering the catheter.An attempt to deflate the balloon was unsuccessful.The balloon was cut and the glue bullet was noted to be seated correctly.No other functional testing was performed.Three photos were provided and reviewed.The first photo shows the conquest 40 balloon with the balloon protector over the distal part of the balloon.The balloon is seen deflated and bloody.The second photo shows the label of the device which matches with the information in trackwise.The third photo shows the luers of the device.No specific abnormalities can be seen.Therefore, the investigation is unconfirmed for the reported inflation issue as the balloon was able to be inflated.However, the investigation is confirmed for the identified material deformation as stretching and bunching was observed on the catheter shaft, and for the identified deflation issue as an attempt to deflate the balloon was unsuccessful.A definitive root cause for the reported inflation issue, identified material deformation and deflation 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate.The procedure was completed using another device.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: 17948157
• Report Number: 2020394-2023-00877
• Device Sequence Number: 12542435
• Product Code: DQY
• UDI-Device Identifier: 00801741060618
• UDI-Public: (01)00801741060618(11)200820(17)230630(10)REEU1564
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2024

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: 06/30/2023
• Device Catalogue Number: CQF7598
• Device Lot Number: REEU1564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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: 79 YR
• Patient Sex: Male