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

Model Number CQ75104

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 06/2023).

Event Description

It was report that during an angioplasty procedure, the device allegedly had an inflation problem.It was further reported that balloon allegedly recoiled very slowly during the deflation.There was no reported patient injury.

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 was returned for evaluation.Bunching of the catheter shaft was noted near the proximal end of the balloon; no other specific anomalies were noted during the visual evaluation.On the functional testing, the returned balloon was inflated with the in-house presto inflation device to 8 atm and it maintained pressure; further, the balloon was inflated to 24 atm, which continued to maintain the pressure.Then the balloon was deflated, and it took 27 seconds for complete deflation, which is within the acceptable limit of the product performance specification.Then the balloon was cut under microscopic observation, the port holes were noted to be collapsed, and the glue bullet was not seated in the correct position.No other functional testing was performed.Therefore, the investigation for the reported inflation issue was unconfirmed as the balloon was able to inflate and maintain pressure at both 8 and 24 atm during the functional testing.The investigation was also unconfirmed for the reported slow deflation as the balloon deflation time took 27 seconds to deflate, which is within the acceptable limit of product performance specifications.However the investigation was confirmed for the identified bunching of the catheter shaft, as the bunching was visible on the returned device during the visual evaluation.A definitive root cause for the reported inflation issue, reported slow deflation and identified bunching of the catheter shaft 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: 06/2023), g3, h6 (device).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.

Event Description

It was report that during an angioplasty procedure, the device allegedly had an inflation problem.It was further reported that balloon allegedly recoiled very slowly during the deflation.There was no reported patient injury.

• Brand Name: CONQUEST
• Type of Device: 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: 15757379
• MDR Text Key: 306164321
• Report Number: 2020394-2022-00879
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

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
• Device Operator: Health Professional
• Device Model Number: CQ75104
• Device Catalogue Number: CQ75104
• Device Lot Number: REEU4166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1