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

Model Number	CQ7588
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
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 device has been returned to the manufacturer for evaluation as well as a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 08/2024).
Event or Problem Description
It was reported that prior to an angioplasty procedure, the distal tip of the pta balloon was allegedly detached from the catheter which was used to connect for inflation.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the distal tip of the pta balloon was allegedly detached from the catheter which was used to connect for inflation.The procedure was completed using another device.There was no patient contact.
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: one photo was reviewed.The photo shows detached inflation luer from the catheter.No other anomalies were noted on the submitted photos.One conquest pta dilatation catheter was returned for evaluation.Other than the inflation luer being detached from the catheter and which was not returned , no other anomalies were noted during the visual evaluation.No functional testing performed due to the nature of the complaint.Therefore, the investigation was confirmed for the reported detachment as the inflation luer noted to be completely detached from the catheter.The reported issue can also be confirmed by the submitted photo.A definitive root cause for the reported detachment 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: d4 (expiration date: 08/2024), g3, h6(method).H11: h6(result, conclusion).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
• 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: 15091210
• Report Number: 2020394-2022-00600
• Device Sequence Number: 4034386
• Product Code: DQY
• UDI-Device Identifier: 00801741063138
• UDI-Public: (01)00801741063138
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: CQ7588
• Device Catalogue Number: CQ7588
• Device Lot Number: REFW1786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 67 YR
• Patient Sex: Female