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

Catalog Number CQF7586

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 07/17/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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.However, photos and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).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.H3 other text : device pending return.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon allegedly got stuck inside the vessel and was not easily removed through the sheath.Reportedly, the balloon was forced out through the sheath while being inflated and removed.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the balloon allegedly got stuck inside the vessel and was not easily removed through the sheath.Reportedly, the balloon was forced out through the sheath while being inflated and removed.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 loaded into an unknown sheath was returned for evaluation.The catheter shaft is noted to be stretched and bunched.The balloon was also noted to be bunched.No other anomalies were noted during the visual evaluation.No functional testing was performed due to the condition of the device.Also, three photos were reviewed.The first and second photo shows the balloon inside a plastic package.The balloon was noted to be bloody and to be in a deflated and unevenly folded condition.The catheter shaft and introducer sheath were severely bunched, and the catheter was still loaded within the introducer sheath.The third photo shows the label of the device, on which all the product details can be verified.No other anomalies were noted.Also, the video was reviewed.From the submitted video, the catheter was seen loaded within the introducer sheath, and the catheter shaft was severely bunched.No other specific anomalies were noted.Therefore, the returned sample analysis of the original device and based on the submitted photos and video, it was confirmed that the catheter was loaded within the introducer sheath and that the shaft was severely bunched.Therefore, the investigation is confirmed for the reported sheath removal difficulty and the identified catheter shaft bunching; however, the investigation remains inconclusive for the reported deflation issue and balloon entrapment within the vessel, as no objective evidence could be noted based on the submitted photos and videos.A definitive root cause for the reported sheath removal difficulty, deflation issue ,balloon entrapment within the vessel and the identified catheter shaft bunching could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 08/2025), 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.

• 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: 17486673
• MDR Text Key: 320762360
• Report Number: 2020394-2023-00574
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060564
• UDI-Public: (01)00801741060564
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K120660
• 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: 10/21/2023

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: CQF7586
• Device Lot Number: REGW2699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/23/2023
• 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