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

Model Number	CQF75124
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.However, a video was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2023).
Event or Problem Description
It was reported that during a venoplasty procedure in the right upper limb, the pta balloon allegedly ruptured.There was no reported patient injury.
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 has returned for evaluation.On the visual evaluation of the device, it appeared bloody, no kinks and no other anomalies noted the device.On the functional evaluation of the device, the guide wire lumen was flushed, and an in-house guide was inserted without any issue.Then the balloon tried to inflate with the in-house presto device, upon inflation water were leaking from the balloon at the proximal end.Upon removing the fibers and examined on microscopic view a compound rupture was noted on the balloon.One video was reviewed.The video shows a conquest balloon appearing partially inflated.Water can be seen dripping from the distal end of the balloon.However, the source of the water cannot be determined from the video and no anomalies can be seen in the video.Therefore, no confirmations can be made based on the video review.Therefore, the investigation has confirmed for reported balloon rupture as a compound balloon rupture were noted when the balloon attempt to inflate and water leaks from the rupture.A definitive root cause for the balloon rupture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.D4(expiry date: 08/2023).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 a venoplasty procedure in the right upper limb, the pta balloon allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one conquest 40 pta dilatation catheter has been returned for evaluation.On the visual evaluation of the device, it appeared bloody, no kinks and no other anomalies noted the device.On the functional evaluation of the device, the guide wire lumen was flushed, and an in-house guide was inserted without any issue.Then the balloon was tried to inflate with the in-house presto device, upon inflation water was leaking from the balloon at the proximal end.Upon removing the fibers and examined on microscopic view a compound rupture was noted on the balloon.One video was reviewed.The video shows a balloon appearing partially inflated.Water can be seen dripping from the distal end of the balloon.However, the source of the water cannot be determined from the video and no anomalies can be seen in the video.Therefore, no confirmations can be made based on the video review.Therefore, the investigation was confirmed for reported balloon rupture as a compound balloon rupture were noted when the balloon was attempted to inflate and water leaks from the rupture and also based on the microscopic observation.A definitive root cause for the balloon rupture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f ¿ the information provide 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 a venoplasty procedure in the right upper limb, the pta balloon allegedly ruptured at 8 atm.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11884001
• Report Number: 2020394-2021-01112
• Device Sequence Number: 14380176
• Product Code: DQY
• UDI-Device Identifier: 00801741060663
• UDI-Public: (01)00801741060663
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup,Followup
• Report Date (Section B): 02/16/2022

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: CQF75124
• Device Catalogue Number: CQF75124
• Device Lot Number: REEW1709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/01/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 02/16/2022
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/21/2021; 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown