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

Model Number CQ75104

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 07/21/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the device was allegedly cannot reach the desired pressure during the inflation.It was further reported that the device allegedly had deflation problem.Reportedly, the removal of the balloon protector was quite tight.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 09/2024).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to reach the desired pressure during inflation.It was further reported that the device allegedly had deflation problem.Reportedly, the removal of the balloon protector was quite tight.The procedure was completed using another device.There was no reported patient injury.

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 pta dilatation catheter was returned for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers, bifurcate or glue fillets.During functional testing, an in-house presto inflation device was used to inflate the balloon.The balloon was inflated and maintained pressure.The balloon was then deflated.The time taken for the deflation was not within the acceptable limit mentioned in the product specification document.The balloon was cut and under microscopic observation, the port holes were noted to be collapsed and the glue bullet was not seated in the correct position.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported difficult to open or remove packaging material as the conditions of use could not be replicated in the lab.The investigation is unconfirmed for the reported failure to inflate as the balloon was inflated and maintained pressure.The investigation is confirmed for the reported failure to deflate as the time taken for the deflation was not within the acceptable limit mentioned in the product specification document.The collapsed port holes is a possible cause of the reported failure to inflate and failure to deflate.The definitive root cause for the reported difficult to remove packaging, failure to inflate and failure to deflate 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.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.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15222529
• MDR Text Key: 302577750
• Report Number: 2020394-2022-00660
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063220
• UDI-Public: (01)00801741063220
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

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: CQ75104
• Device Catalogue Number: CQ75104
• Device Lot Number: REFX3261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/13/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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