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

Model Number	CQ75104
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).
Event or Problem Description
It was reported that during an angioplasty procedure in the left arm brachial vein stenosis, the pta balloon allegedly failed to deflate.It was further reported that the device was allegedly had retraction issue through the sheath.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 pta dilatation catheter has returned for evaluation.A visual evaluation was performed and a cut was noted due to the user puncturing to deflate the balloon.No other anomalies were noted to device.A functional evaluation was performed and the device guide wire lumen was flushed, and an in-house guide wire was inserted without any issue.An attempt was made to inflate the device with an inhouse presto device, but the balloon was initially unable to inflate.The pressure was increased and fluid began to leak from the cut in the balloon.The balloon was then cut to examine the inflation lumen.Under the microscopic observation it was noted the inflation/deflation ports on the inflation lumen were collapsed.The glue bullet was also noted to be not seated correctly.Therefore, the investigation has confirmed for reported deflation issue as the deflation holes were noted to be collapsed.The investigation is also confirmed for the reported retraction issue as the glue bullet was noted to be not seated in the correct position.The deflation issue is likely the cause of the retraction issue.The collapsed deflation port is the likely cause of the deflation issue.However, the definitive root cause of the deflation issue is unknown.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: b5, d4 (expiry date: 10/2023), g3 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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure in the left arm brachial vein stenosis, the pta balloon allegedly failed to deflate.It was further reported that the device was allegedly had retraction issue through the sheath.Another device was used to complete the procedure.There was no reported patient injury.

• 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: 11512530
• Report Number: 2020394-2021-00595
• Device Sequence Number: 17165763
• Product Code: DQY
• UDI-Device Identifier: 00801741063220
• UDI-Public: (01)00801741063220
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/10/2021

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: CQ75104
• Device Catalogue Number: CQ75104
• Device Lot Number: REEY2042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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