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

Model Number	CQ7576
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
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 return of the sample is pending.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.(expiration date: 06/2024).
Event or Problem Description
It was reported that during a digital subtraction angiography guided angioplasty procedure through calcified tissue, the balloon was allegedly difficult to remove.It was further reported that the balloon was removed from the patient body and the procedure was completed using another device.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.One radio graphic image and one photo were received and reviewed.The fluoroscopic image centered around the left arm shows a wire within the left arm and coursing within the chest.Based on the trajectory of the wire, it is likely traveling within the venous system.A stent is seen within the left chest, likely within the axillary vein.Also demonstrated in this image is an almost completely deflated angioplasty balloon.This appears to the left of the image near the patient¿s elbow.The provided images show an angioplasty balloon within the patient¿s arm, but further imaging or videos are needed to confirm the complaint.The photos show the distal end of the balloon and it appears bloody.The balloon was noted to be stuck with the introducer sheath.The distal end of the sheath was noted to be deformed.No other specific anomalies were noted from the provided photo.Therefore, the investigation remains inconclusive for the reported difficult to insert balloon through the sheath as no objective evidence could be noted from the provided radiographic image and submitted photo.However, the investigation was confirmed for the reported difficulty in removing the balloon from the sheath as the balloon was noted to be stuck within the introducer sheath which was observed from the provided photo.A definitive root cause for the reported difficult to insert , device-device incompatibility and difficult to remove 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 (expiration date: 06/2024), 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 a digital subtraction angiography guided angioplasty procedure through calcified tissue, the balloon was allegedly difficult to remove.It was further reported that resistance was allegedly felt upon inserting the sheath.Reportedly, the balloon was removed from the patient body and the procedure was completed using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14904339
• Report Number: 2020394-2022-00530
• Device Sequence Number: 15023553
• 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): 07/29/2022

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: REFU4047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 08/09/2022
• 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: 39 YR
• Patient Sex: Female