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

Model Number	CQ7594
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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: 08/2023).
Event or Problem Description
It was reported that during the angioplasty procedure, the device allegedly failed to deflate.There was no reported patient injury.
Event or Problem Description
It was reported that during the angioplasty procedure, the device allegedly failed to deflate.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 dilatation catheter has returned evaluation.On the visual evaluation of the device, it appeared bloody, and no specific anomalies noted.On the functional evaluation of the device the in-house guide wire lumen was flushed and the in-house guide wire able to advance through the catheter without any issue.On further the balloon inflated with the in-house presto device and the balloon able to inflate and maintain the shape and pressure, no rupture was present.Then the balloon was attempts to deflate, initially it was noted to deflate but on further it was observed the device not deflated and the timer was stopped after 26 seconds after no signs of deflation.After some time, the balloon eventually deflated.Then the balloon was cut and observed the port holes were collapsed.All the anomalies noted on the microscopic observation.Therefore, the investigation has conformed for the reported deflation issue as the balloon deflation time as exceed above the product performance specification limit.It is likely the collapsed port holes contributed to the identified deflation issue.However, the definitive root cause for the deflation issue could not be determined based upon the available 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: 08/2023),g3,h6(method) h11: h6(result and 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.See h10.

• Brand Name: CONQUEST 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: 11759029
• Report Number: 2020394-2021-00953
• Device Sequence Number: 2939831
• Product Code: DQY
• UDI-Device Identifier: 00801741063190
• UDI-Public: (01)00801741063190
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K083657
• 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): 06/14/2021

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: CQ7594
• Device Catalogue Number: CQ7594
• Device Lot Number: REEW4537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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