MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; PTA BALLOON DILATATION CATHETER

Model Number U4150510

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 03/07/2022

Event Type  malfunction  

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: 09/2024).

Event Description

It was reported that during an angioplasty procedure in the left lower extremity, the pta balloon was allegedly stuck to the wire and could not pull back.It was further reported that balloon and wire were removed together.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the left lower extremity, the pta balloon allegedly got stuck in the command wire.It was further reported that the balloon and the wire were removed together.There was no reported patient injury.

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 014 pta dilatation catheter was received for evaluation loaded onto a unknown guidewire and with an unknown introducer sheath loaded over it.During visual evaluation, the sample was received with an unknown guide-wire extending out the distal end of the catheter.Stretching was observed to the outer catheter just proximal to the balloon weld.The balloon had a break at the proximal glue weld with the inner guide-wire lumen was intact.Bunching was observed to the guide-wire lumen.No kinks were noted to the catheter shaft and no anomalies to the luers/y-body.During functional testing, an attempt was made to remove the returned guide-wire but was unsuccessful.No further functional testing was conducted.Therefore, the investigation is confirmed for the reported difficult to remove and device-device incompatibility as the catheter was received loaded onto a unknown guidewire and bunching was observed to the guide-wire lumen.The investigation is also confirmed for the identified difficult to remove as the catheter was received with an unknown introducer sheath loaded over it.The investigation is also confirmed for the identified break as the balloon had a break at the proximal glue weld with the inner guide-wire lumen intact.A definitive root cause for the reported difficult to remove, device-device incompatibility and identified difficult to remove, break 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: 09/2024), g3, h6 (method).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.

• Brand Name: ULTRAVERSE 014
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13995199
• MDR Text Key: 288519796
• Report Number: 2020394-2022-00253
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741054167
• UDI-Public: (01)00801741054167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U4150510
• Device Catalogue Number: U4150510
• Device Lot Number: CMFX0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 66 KG