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

Model Number U41502H4RX

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2022

Event Type  Injury  

Event 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.

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).

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 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
• Type of Device: 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
• MDR Text Key: 291714666
• Report Number: 2020394-2022-00372
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056475
• UDI-Public: (01)00801741056475
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male