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

Catalog Number CQ5064J

Device Problems Inflation Problem (1310); Unraveled Material (1664); Material Deformation (2976)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate at the tip.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the conquest pta balloon dilatation catheter products that are cleared in the us.The pro code and 510 k number for the conquest pta balloon dilatation catheter products are identified in d2 and g4.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 loaded along with an unknown inflation device was returned for evaluation.Unraveled fibers and fiber disturbance were able to be noticed on the returned balloon.No other anomalies were noted during the visual evaluation.During functional testing, the balloon was attempted to inflate with the returned inflation device but it was unsuccessful.Furthermore, the balloon was inflated with the in-house presto inflation device.The balloon was able to inflate to 8atm, maintaining shape and pressure.Then the inflated balloon was deflated without any problems.All the anomalies are noted by microscopic observation.Unraveled fibers and fiber disturbance were able to be noticed on the returned balloon during the visual and microscopic observation.Then the balloon was unable to inflate with the returned unknown inflation device.However, under a laboratory-controlled environment, the returned balloon was able to inflate fully, maintaining pressure and shape, then deflated without any problems.Therefore, the investigation was confirmed for the identified unraveled fiber and fiber disturbance.However, the investigation for the reported inflation issue was unconfirmed.A definitive root cause for the reported inflation issue and identified unraveling of fiber 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 (expiration date: 01/2025).The information provided 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.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the conquest pta balloon dilatation catheter products that are cleared in the us.The pro code and 510 k number for the conquest pta balloon dilatation catheter products are identified in d2 and g4.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 loaded along with an unknown inflation device was returned for evaluation.Unraveled fibers and fiber disturbance were able to be noticed on the returned balloon.No other anomalies were noted during the visual evaluation.In the functional testing, the balloon was attempted to inflate with the returned inflation device but it was unsuccessful.Furthermore, the balloon was inflated with the in-house presto inflation device.The balloon was able to inflate to 8atm, maintaining shape and pressure.Then the inflated balloon was deflated without any problems.All the anomalies under microscopic observation.Unraveled fibers and fiber disturbance were able to be noticed on the returned balloon during the visual and microscopic observation.Therefore, the investigation was confirmed for the identified unraveled fiber and fiber disturbance.Then the balloon was unable to inflate with the returned unknown inflation device.However, under a laboratory-controlled environment, the returned balloon was able to inflate fully, maintaining pressure and shape, then deflated without any problems.Hence, the investigation for the reported abnormal inflation issue was unconfirmed.A definitive root cause for the reported abnormal inflation issue identified unraveled fiber 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 (expiration date: 01/2025).H11: section a through f ¿ the information provided 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 Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate at the tip.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: 16953184
• MDR Text Key: 315565363
• Report Number: 2020394-2023-00347
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741127182
• UDI-Public: (01)00801741127182
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/22/2023

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 Catalogue Number: CQ5064J
• Device Lot Number: REGP2669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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