MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number U8130622

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

It was reported that there was a residue on the pta balloon noticed upon removal from the packaging.The balloon was not used.Another balloon was used to perform the procedure.There was no patient involvement.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.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 to any further patient, product, or procedural details to bard.

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Visual/microscopic inspection:the balloon guard and stylet were returned in their initial positions on the balloon.The balloon guard and stylet were removed from the catheter during while taking pictures during the decontamination process.The hub indicates 6.0mm x 220mm x 130cm.No anomalies were noted to the balloon or along the length of the catheter.The balloon was examined under microscopic magnification and the hydrophilic coating on the balloon was not uniform throughout the length of the balloon.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.018" guidewire and it passed without issue.The inflation hub was connected to an inflation device and the balloon was inflated to nominal pressure.The hydrophilic coating on the balloon was not uniform throughout the length of the balloon.No strings of hydrophilic coating were observed coming off the tip of the balloon.Medical records/image/photo review: no medical records or medical images have been made available to the manufacturer.Conclusion: the device was returned.The investigation is unconfirmed for foreign material present in the device, as the material present on the balloon was the hydrophilic coating and was not foreign to the device.The reported event details of strings of hydrophilic coating coming off the balloon and the presence of blood on the returned balloon suggests that the user may have activated the hydrophilic coating on the balloon.However, the root cause for the reported event is unknown.The condition of the returned balloon would have met the acceptance criteria at the manufacturing site, as the uniformity of the hydrophilic coating was only visible under microscopic magnification.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.In order to activate the hydrophilic coating, it is recommended to wet the ultraverse catheter with sterile saline solution immediately prior to its insertion in the body.Dilatation catheter preparation: remove catheter from package.Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled.Remove the balloon guard and stylet by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter.(b)(4).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.

• Brand Name: ULTRAVERSE 018 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4906443
• MDR Text Key: 19610780
• Report Number: 2020394-2015-01015
• Device Sequence Number: 1
• Product Code: DQY
• 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: Company Representative,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2015

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 Expiration Date: 01/31/2018
• Device Catalogue Number: U8130622
• Device Lot Number: 50117965
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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