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

Model Number U357584

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 08/2022).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 Description

It was reported that during an angioplasty procedure in the common iliac artery via an ipsilateral retrograde approach, the pta balloon was allegedly unable to cross the lesion.It was further reported that the device allegedly seemed like being stuck with the distal part of the stent.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the common iliac artery via an ipsilateral retrograde approach, the pta balloon was allegedly unable to cross the lesion.It was further reported that the device allegedly seemed like being stuck with the distal part of the stent.The procedure was completed using another device.There was no reported patient injury.

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 o35 pta dilatation catheter was received for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers/y-body.During functional testing, the guide-wire lumen and in-house sheath were flushed, then the balloon was loaded onto the guide-wire.The balloon was aspirated prior to inserting into the sheath.The sample was inserted into the sheath without issue and once inside of the sheath, the balloon was inflated and maintained pressure without issue.The sample was able to be retracted without issue.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported unable to cross lesion and entrapment since the conditions of use cannot be replicated in the lab.A definitive root cause for the alleged unable to cross lesion and entrapment 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: 08/2022), 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 035
• 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: 14520587
• MDR Text Key: 292794387
• Report Number: 2020394-2022-00417
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142261
• 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: 07/01/2022

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
• Device Operator: Health Professional
• Device Model Number: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMDW0401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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