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

Model Number CQ7584

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.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 Description

It was reported that during an angioplasty procedure, the balloon allegedly cannot deflate fully.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one conquest pta dilatation catheter was received for evaluation with an unknown sheath over the balloon and three way stop cock attached to the inflation luer.Under microscopic examination, buckling was noted to the distal end of the sheath with the balloon partially inflated.During functional evaluation, negative pressure was applied but was unsuccessful.An attempt was made to remove the balloon from the sheath, but strong resistance was felt with no success of removing the balloon.No other functional testing was performed.Also, one photo was provided and reviewed.The photo shows an unknown sheath loaded over the conquest balloon.Buckling is noted to the distal end of the sheath with the distal end of the balloon visible and partially inflated.Therefore, the investigation is confirmed for the reported deflation problem and sheath removal difficulty as the device was returned with an unknown sheath over the balloon which was partially inflated, and attempts to deflate the balloon and remove the sheath were unsuccessful.The failures are also confirmed from the review of the provided photo.A definitive root cause for the reported deflation problem and sheath removal difficulty 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, g3, h6 (device) h11: h6 (method, result, conclusion) 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 Description

It was reported that during an angioplasty procedure, the balloon allegedly could not deflate fully.It was further reported that it was difficult to remove the device.The procedure was completed by using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16917388
• MDR Text Key: 315073662
• Report Number: 2020394-2023-00330
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• 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