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

Model Number	U4150530RX
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified target lesion in the superficial femoral artery, the pta balloon allegedly failed to deflate.It was further reported that balloon allegedly difficult to be 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.(expiry date: 03/2024).
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 rx catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.In the functional testing, the inner guide wire lumen was flushed and an in-house guide wire was inserted into the catheter without any issue.In addition, the in-house introducer sheath was flushed and attempted to insert into the catheter but failed due to dry contrast and balloon condition.Then the balloon was inflated up to 13 atm with an in-house presto inflation device.The balloon inflated and maintained pressure.Then the balloon deflated without any issue and took 28 seconds to deflate.No other functional testing was performed.As per the design input requirement the deflation time take during the sample evaluation was within the acceptable limit.Therefore, the investigation for the reported deflation issue was unconfirmed as the device was able to inflate and deflate without any issue during the functional testing and the deflation time taken during the functional testing is within the acceptable limit as per the design input requirement.However, the investigation for the reported difficulty in removing from the sheath remains inconclusive as the in-house sheath couldn¿t be inserted into the catheter due to the dry contrast and the condition of the device, no further testing couldn¿t be performed.A definitive root cause for the reported deflation issue, reported difficulty in removing from the sheath 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: (expiry date: 03/2024).H11: section a through f ¿ the information provide 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 of a calcified target lesion in the superficial femoral artery, the pta balloon allegedly failed to deflate.It was further reported that balloon allegedly difficult to be removed from the sheath.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• 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: 15333794
• Report Number: 2020394-2022-00700
• Device Sequence Number: 6956188
• Product Code: LIT
• UDI-Device Identifier: 00801741058035
• UDI-Public: (01)00801741058035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• 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): 10/14/2022

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: U4150530RX
• Device Catalogue Number: U4150530RX
• Device Lot Number: CMFR0294
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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: Female