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

Model Number	CQ7576
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, photos and videos were provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, pta balloon allegedly had deflation issue.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: the physical device was not returned for evaluation.Two videos were reviewed.The first video shows the conquest balloon connected to an inflation device.The health professional tries to inflate the balloon using the inflation device but it is unsuccessful.The second video shows the health professional inspecting the balloon connected to the inflation device which does not inflate.Therefore, based on the first video, the reported inflation problem can be confirmed since the balloon is unable to be inflated.The reported deflation problem remains inconclusive since testing for deflation is not seen.Two photos were reviewed.The first photo shows the conquest balloon connected to an inflation device to which pressure has been applied but the balloon remains deflated.The second photo shows the conquest balloon connected to an inflation device to which pressure has been applied but the balloon remains deflated.Therefore, based on the photo reviews, the reported inflation problem and deflation problem remain inconclusive since sufficient evidence is not provided to confirm the failures.Therefore, the investigation is confirmed for the reported inflation problem since the balloon does not inflate based on the first video.The investigation is inconclusive for the reported deflation problem since no testing for deflation can be seen.A definitive root cause for the alleged inflation problem and deflation problem 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.H10: b5, d4 (expiry date: 11/2023), g3, h6(device, method).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, pta balloon allegedly had inflation and deflation issue.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13042040
• Report Number: 2020394-2021-02087
• Device Sequence Number: 12114955
• Product Code: DQY
• UDI-Device Identifier: 00801741063008
• UDI-Public: (01)00801741063008
• 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
• Report Date (Section B): 01/10/2022

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: CQ7576
• Device Catalogue Number: CQ7576
• Device Lot Number: REEZ2210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/15/2022
• 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 Age: 83 YR
• Patient Sex: Female