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

Model Number CQ7584

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

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: the physical device was not returned for evaluation.Two videos were reviewed.The first video shows the balloon catheter being connected to an unknown inflation device.The balloon noted to be partially inflated, upon pressurizing the balloon inflated fully, without any abnormal inflation.Upon depressurizing to 0 atm, the balloon is noted to be inflated and does not deflate.The second video shows the fully inflated balloon and starts to deflate.The balloon partially deflated and the distal end of the balloon noted to be in partially inflated, condition.Therefore, based on the photo review, the reported deflation issue can be confirmed; however, the reported inflation issue could not be confirmed on the findings, no conclusion can be made.Therefore, based on the submitted videos, the investigation for the reported deflation issue was confirmed as the balloon could not be deflated fully during the depressurization of the device.However, the investigation for the reported inflation issue remains inconclusive as the balloon could have been inflated.But the condition of use within the patient could not able be replicated from the submitted video, and no evidence of slow deflation or abnormal inflation could not be noted.A definitive root cause for the reported inflation issue and deflation issue 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.(expiry date: 03/2023).

Event Description

It was reported that during an angioplasty procedure in the right arm to treat central venous stenosis, the physician allegedly felt resistance while inflating the balloon with inflator.It was further reported that the balloon allegedly failed to deflate.However, the surgeon retracted the balloon inside the sheath and removed from the patient.There was no reported patient injury.

• Brand Name: CONQUEST
• Type of Device: 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: 13684871
• MDR Text Key: 286743721
• Report Number: 2020394-2022-00150
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

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
• Device Operator: Health Professional
• Device Model Number: CQ7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REER0704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female