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

Model Number U357592

Device Problems Difficult to Insert (1316); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.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: 09/2019).The information provided by bard 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 bard.

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to insert through the sheath.It was further reported that the pta balloon had difficulty retracting through the sheath.There was no reported patient injury.

Manufacturer Narrative

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: the device was returned with a 6fr terumo sheath for evaluation.A visual inspection was completed and was unable to identify anomalies contributing to the failure.During functional evaluation the device passed without issue.Therefore, the investigation is unconfirmed for difficult to insert and retraction problem as the event was unable to be recreated.The definitive root cause for the reported insertion and retraction issue could not be determined based upon the available information.Labeling review:the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly difficult to insert through the sheath.It was further reported that the pta balloon had difficulty retracting through the sheath.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 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: 7719441
• MDR Text Key: 115015148
• Report Number: 2020394-2018-01282
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741094330
• UDI-Public: (01)00801741094330
• Combination Product (y/n): N
• PMA/PMN Number: K142261
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U357592
• Device Catalogue Number: U357592
• Device Lot Number: CMAX0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68