MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF7564
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2024).
Event or Problem Description
It was reported that prior to a procedure, the packaged arrived damaged and the catheter was noted to be damaged as well.There was no patient contact.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One photo was reviewed.The photo shows the conquest 40 outer and inner carton pack, the catheter can be noted inside the inner package, the outer package noted be teared and inner carton noted to crushed, no evidence of catheter damage or breach of sterile barrier.No no other specific anomalies noted.Therefore, based on the photo review, the reported device damage prior to use and package issue could not be confirmed as no evidence of device damage noted from the submitted photo and it is also unknown whether the tear happened due to handling of the package by the user and user also not reported any tear or damage noted on the outer package of the catheter.Therefore the investigation for the reported packaging problem and device damage prior to use remains inconclusive as no specific damage or breach of sterile barrier to the package and the device noted on the submitted photo.A definitive root cause for the reported packaging problem and device damage prior to use 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 (expiry date: 02/2024), g3, h6(method).H11: h6(device, 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.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to a procedure, the package arrived damaged and the catheter allegedly was noted to be damaged as well.There was no patient contact.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12363947
• Report Number: 2020394-2021-01501
• Device Sequence Number: 4333802
• Product Code: DQY
• UDI-Device Identifier: 00801741060441
• UDI-Public: (01)00801741060441
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: CQF7564
• Device Catalogue Number: CQF7564
• Device Lot Number: REFQ3051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 10/23/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1