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

Catalog Number U357584

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

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. 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 preparation for an angioplasty procedure the health care provider noticed that the pta balloon sterile packaging had allegedly been opened. There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Visual/microscopic inspection: the sample was returned clean outside of the packaging hoop inside the inner packaging pouch. The inner packaging pouch was returned opened. No other anomalies were noted to the inner packaging pouch. The outer packaging was returned opened. The catheter was removed from the inner packaging pouch and the hub on the pta balloon indicates 8mm x 40mm. No anomalies were noted to the packaging hoop or the catheter upon removal from the inner packaging pouch. It was observed that the balloon protector and stylet were still in place on the balloon. A kink in the catheter was present 35. 5cm from the distal tip. It is unknown when the kink occurred, as it was not reported by the user. The balloon protector and stylet were removed from the catheter and no anomalies were noted to the balloon. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the sample was returned with opened inner and outer packaging. The investigation is inconclusive for a packaging issue, as the inner packaging pouch was returned open and no packaging anomalies were found on the returned sample or packaging. It is unlikely that the root cause is manufacturing related as inner packaging is verified as fully sealed. It is possible that shipping/handling or user related issues in opening the product packaging contributed to the event. However, the definitive root cause could not be determined based upon the available information. Labeling review: the current ifu (instructions for use) states: warnings: do not exceed the rbp recommended for this device. Balloon rupture may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. 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. Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure. 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 preparation for an angioplasty procedure the health care provider noticed that the pta balloon sterile packaging had allegedly been opened. There was no reported patient contact.

• Brand Name: ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
• 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 ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6380316
• MDR Text Key: 69169506
• Report Number: 2020394-2017-00150
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Catalogue Number: U357584
• Device Lot Number: CMAU0286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial