MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. HIGHLANDER 014; PTA BALLOON DILATATION CATHETER

Catalog Number	H41502H15
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional 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.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that during an angioplasty procedure in the severely calcified below knee superficial femoral artery via the contralateral approach, the pta balloon allegedly ruptured at 10 atm.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.Investigation summary: one highlander 014 was returned for evaluation.An in-house presto inflation device was used to inflate the balloon, during the inflation a leak could be seen at the proximal balloon joint.The exact source of the leak could not be determined.No other rupture was noted to the device.No other functional testing performed.Therefore, the investigation is unconfirmed for the reported balloon rupture as no rupture was noted to the balloon.However, the investigation is confirmed for the identified leak, as leak could be seen at the proximal balloon joint.And the investigation remains inconclusive for the reported lesion advancement difficulty as the reported scenario cannot be replicated in laboratory.Per the reported event details, the target lesion was highly calcified.Therefore, it is possible the interaction between the lesion and the balloon contributed to the reported balloon rupture.However, the definitive root cause for the reported balloon rupture, lesion advancement difficulty and identified leak could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.
Event or Problem Description
It was reported that during an angioplasty procedure in a severely calcified superficial femoral artery via contralateral approach, there was difficulty in passing the tip of the pta balloon through the lesion but somehow passed and dilation was started.It was further reported that the balloon allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: HIGHLANDER 014
• 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: 21032683
• Report Number: 2020394-2024-01918
• Device Sequence Number: 4120511
• Product Code: LIT
• UDI-Device Identifier: 00801741213458
• UDI-Public: (01)00801741213458(11)230928(17)250831(10)CMHW0412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K223177
• 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): 03/07/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: H41502H15
• Device Lot Number: CMHW0412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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