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

Model Number CQF75122

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

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

Event Date 07/08/2022

Event Type  malfunction  

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.Expiration date: (expiry date: (b)(4) 2024) 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.Device pending return.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly had deflation issue.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the balloon allegedly had deflation issue.It was further reported that the device was allegedly difficult to remove.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one conquest 40 pta dilatation catheter with a loaded unknown sheath, was returned for evaluation.No specific anomalies were noted during the visual evaluation.On the microscopic observation, a bond joint break was observed and the distal end of the balloon was noted to prolapse.No functional testing was performed due to the condition of the device returned for evaluation.The investigation into the reported deflation issue will remain inconclusive as the functional testing couldn¿t be performed due to the condition of the device returned for evaluation.The investigation for the reported difficult to remove was confirmed as the catheter was loaded into an unknown sheath and returned for evaluation.The investigation was also confirmed for the identified the break as a bond joint break was able to be observed between the catheter and balloon under microscopic observation.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: b5, d4 (expiry date: 04/2024), g3, h6 (device).H11: h6 (method, 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.

• Brand Name: CONQUEST 40
• 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: 15144534
• MDR Text Key: 297050694
• Report Number: 2020394-2022-00629
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060656
• UDI-Public: (01)00801741060656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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: CQF75122
• Device Catalogue Number: CQF75122
• Device Lot Number: REFS1396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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