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

Model Number U4150230RX

Device Problem Material Deformation (2976)

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

Event Date 03/31/2021

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: 08/2022).

Event Description

It was reported that during an angioplasty procedure, the catheter shaft was allegedly kinked.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the catheter shaft was allegedly kinked.It was further reported that another device was used to complete the procedure.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 rx pta dilatation catheter in two segments has returned for evaluation, however the detachment of catheter was observed to be an incidental finding.On the visual evaluation of the returned device, it consists of two segments in detached potions, a kink was noted right next the detached catheter end.No other anomalies noted.No functional performed due to the condition of the device returned for evaluation.Therefore, the investigation for the reported material deformation was confirmed for, as the catheter was returned for evaluation with a kink.A definitive root cause for the alleged material deformation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2022).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 RX PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11730429
• MDR Text Key: 247455979
• Report Number: 2020394-2021-00923
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056383
• UDI-Public: (01)00801741056383
• Combination Product (y/n): N
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U4150230RX
• Device Catalogue Number: U4150230RX
• Device Lot Number: CMDW0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 80