MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018; PTA BALLOON DILATATION CATHETER

Catalog Number U813034

Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/08/2023

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.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.Device pending return.

Event Description

It was reported that during an angioplasty procedure, the guidwire allegedly caught midway through after flushing the product with saline.It was further reported that the procedure was discontinued use due to black foreign matter appearing.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the guidewire allegedly got caught midway through after flushing the product with saline.It was further reported that the procedure was discontinued due to appearence of black foreign matter.The procedure was completed using another device.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 ultraverse 018 dilatation catheter was returned for evaluation.No foreign matter was noted on the returned catheter and no other anomalies were noted during the visual evaluation.On the functional testing, the guide wire lumen was flushed with light resistance by using the in-house syringe.Further the in-house guide wire was able to insert with slight resistance.Further the catheter was able to insert into the in-house sheath without any issue.No other functional testing performed.As no foreign matter was noted on the return to the catheter and during the functional testing, the in-house guide wire was inserted into the catheter without any issue.Therefore, the investigation for the reported foreign contamination and guide wire advancement issue was unconfirmed.A definitive root cause for the reported foreign contamination and guide wire advancement issue 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: b5, d4 (expiry date: 10/2024), g3.H11: h6 (method, result, conclusion).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.

• Brand Name: ULTRAVERSE 018
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18490457
• MDR Text Key: 332613392
• Report Number: 2020394-2024-00018
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741054624
• UDI-Public: (01)00801741054624
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192318
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: U813034
• Device Lot Number: CMFY0614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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