MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Model Number	U3575102
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the right common iliac artery, the pta balloon allegedly unable to be advanced and difficult to be removed from the sheath.It was further reported that the device was removed along with the sheath.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: 07/2024).
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 035 pta dilatation catheter loaded in an unknown sheath was returned for evaluation.No other specific anomalies were noted during the visual evaluation.The balloon was noted to be stuck and no functional testing was performed due to the condition of the device.The investigation remains inconclusive for the reported sheath insertion failure into the catheter as the functional testing couldn¿t be performed due to the condition of the device returned for evaluation.However, the investigation was confirmed for the reported sheath removal failure from the catheter as the balloon was noted to be stuck within the catheter and returned for evaluation.A definitive root cause for the reported sheath insertion failure into the catheter and reported sheath removal failure from the catheter 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: d4 (expiry date: 07/2024), 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the right common iliac artery, the pta balloon allegedly unable to be advanced and difficult to be removed from the sheath.It was further reported that the device was removed along with the sheath.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 15507318
• Report Number: 2020394-2022-00773
• Device Sequence Number: 17410801
• Product Code: LIT
• UDI-Device Identifier: 00801741094576
• UDI-Public: (01)00801741094576
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142261
• 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): 11/02/2022

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: U3575102
• Device Catalogue Number: U3575102
• Device Lot Number: CMFV0304
• 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: 09/09/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/12/2022
• 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: Unknown