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

Catalog Number	U813034
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2020394-2024-00018
• Device Sequence Number: 3666234
• Product Code: LIT
• UDI-Device Identifier: 00801741054624
• UDI-Public: (01)00801741054624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown