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

Model Number	CQF75124
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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.The investigation of the reported event is currently underway.(expiry date: 12/2023).
Event or Problem Description
It was reported that during angioplasty procedure the balloon allegedly had inflation problem.It was further reported that the balloon had deflation problem and it was difficult to remove.There was no patient injury.
Event or Problem Description
It was reported that during angioplasty procedure the balloon allegedly had inflation problem.It was further reported that the balloon had deflation problem and it was difficult to remove.There was no reported patient injury.
Additional Manufacturer Narrative
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: one conquest 40 pta dilatation catheter device was returned for evaluation.The returned device was noted to be bloody.Bunching was noted near the proximal end of the balloon.No other anomalies were noted.During functional testing, returned device was attempted to inflate using an inhouse presto inflation device.The balloon was noted to partially inflate and did not fully deflated.No other functional testing was done.The investigation is confirmed for the reported inflation and deflation problem, as the device was not able to inflated or deflated during the sample evaluation.The investigation is inconclusive for the reported difficult to remove due to the state of the device and no functional testing performed.The investigation is inconclusive for the reported difficult to open or remove packaging, as it cannot be reciprocated/tested in the lab environment.The pinching of the port holes noted during evaluation most likely lead to the reported inflation and deflation issues.The reported deflation issues most likely contributed to the difficulty in removing.However, the definitive root cause for the reported inflation problem, deflation problem, difficult to remove and difficult to open or remove packaging could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2023), g3, h6 (device, method) h11: h6 (result, conclusion) h11: section a through f ¿ the information provide 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.2020394-2021-01085-1.

• 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: 11861473
• Report Number: 2020394-2021-01085
• Device Sequence Number: 4414642
• Product Code: DQY
• UDI-Device Identifier: 00801741060663
• UDI-Public: (01)00801741060663
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/17/2021

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: CQF75124
• Device Catalogue Number: CQF75124
• Device Lot Number: REFN0624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other