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

Model Number	U41502H4
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured during first inflation.It was further reported that the balloon was removed.There was no reported patient injury.
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.(expiration date: 03/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at first inflation attempt.It was further reported that the balloon was removed.There was no reported patient injury.
Additional 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 ultraverse 014 pta dilatation catheter was returned for evaluation.No specific anomalies were noted during visual evaluation.During the functional testing, the balloon was inflated with an in-house presto inflation device.The balloon maintained pressure up to 15 atm.No evidence of rupture was noted and no other functional testing was performed.Therefore, the investigation for the reported balloon rupture is unconfirmed as the balloon was inflated without any issue and no evidence of rupture was noted during the evaluation testing.A definitive root cause for the reported balloon rupture 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: b5, d4 (expiration date: 03/2023), g3.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: ULTRAVERSE 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: 15318719
• Report Number: 2020394-2022-00693
• Device Sequence Number: 17450639
• Product Code: LIT
• UDI-Device Identifier: 00801741053504
• UDI-Public: (01)00801741053504
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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 Model Number: U41502H4
• Device Catalogue Number: U41502H4
• Device Lot Number: CMER0323
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male