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

Model Number	U41502H4RX
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified target lesion in the right anterior tibial artery via contralateral approach, the pta balloon was allegedly trapped by the calcification of the lesion and unable to come off.It was further reported that the shaft was detached from the tip and fragments remained in the patients body.Reportedly, the right common femoral artery was incised and the balloon shaft was taken out.The current patient status is unknown.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 12/2023).
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 pta dilatation catheter in two segments was received for evaluation.During visual evaluation, segment 1 was noted to consist of the the inflation luer and catheter shaft.Segment 2 was noted to consist of the catheter shaft and the balloon.Functional testing could not be performed due to the condition of the returned sample.Therefore, the investigation is confirmed for the reported detachment as the catheter was received detached in two segments.The investigation is inconclusive for the reported entrapment of device as the conditions of use cannot be replicated in the lab.A definitive root cause for the reported detachment and entrapment of device 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.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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified target lesion in the right anterior tibial artery via contralateral approach, the pta balloon was allegedly trapped by the calcification of the lesion and unable to come off.It was further reported that the shaft was detached from the tip and fragments remained in the patients body.Reportedly, the right cfa was incised and the balloon shaft was taken out.The current patient status is unknown.

• Brand Name: ULTRAVERSE RX
• 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: 14403833
• Report Number: 2020394-2022-00372
• Device Sequence Number: 5551476
• Product Code: LIT
• UDI-Device Identifier: 00801741056475
• UDI-Public: (01)00801741056475
• 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): 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U41502H4RX
• Device Catalogue Number: U41502H4RX
• Device Lot Number: CMFN0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male