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

Model Number CQ7584

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the device was removed together with sheath.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2024).

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 balloon loaded onto an unknown sheath was returned for evaluation.During visual evaluation, it was noted that the distal tip of the guidewire lumen was buckled and a circumferential break was noted at the glue joint.Balloon was also noted to be slightly prolapsed.No other anomalies were noted.No functional testing due to the condition of the balloon therefore, the investigation remains inconclusive for the reported deflation issue as no functional testing could not be performed due to the condition of the device.However, the investigation is confirmed for the reported difficult to remove as the catheter was noted to be stuck and loaded with an unknown introducer sheath and returned for evaluation.The investigation is also confirmed for the identified break as a circumferential break was noted at the glue joint during visual evaluation.A definitive root cause for the reported deflation issue, difficult to remove and identified break 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(device).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.

Event Description

It was reported that during an angioplasty procedure of arteriovenous shunt, the pta balloon allegedly had deflation issue.It was further reported that the device was allegedly difficult to remove from the sheath.Reportedly, the device was removed together with the sheath.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: 14102798
• MDR Text Key: 289206326
• Report Number: 2020394-2022-00294
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063114
• UDI-Public: (01)00801741063114
• 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
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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: CQ7584
• Device Catalogue Number: CQ7584
• Device Lot Number: REFQ1971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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