MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE FLOW DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Catalog Number TF0243514

Device Problems Peeled/Delaminated (1454); Retraction Problem (1536); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

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 an aortic valvuloplasty, one of the eight balloons allegedly ruptured after four seconds of inflation using a 30cc syringe.There was no reported retraction issues.The balloon was replaced with a new aortic valve to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 24mm x 3.5cm balloon.The outer balloon jacket was received completely detached from the balloon.However, per the reported event details the technician completely removed the jacket from the balloon after the procedure was completed.A small amount of fluid was still present inside the balloons, indicating that the balloons were not completely deflated.No other anomalies were noted to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was then tested using an in-house 0.035¿ guidewire, and it passed with no issues.The inflation hub was then connected to a max30 inflation device and an attempt was made to inflate the balloon with water.Upon inflation, water was observed leaking from one of the balloons.The balloon was placed under microscopic magnification (10x) and a longitudinal rupture was observed on the barrel of the balloon, measuring 4.6cm in length.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: three electronic photos were reviewed by derrick loud (field assurance engineer).The first two photo show the balloon profile of a true flow valvuloplasty perfusion catheter placed on a gauze pad.The outer balloon jacket is partially peeling off of the balloon and prolapsed over the distal portion of the jacket.The balloon does not appear to be completely deflated.One of the balloons appears to be more deflated that the rest of the balloons.The third photo shows the outer balloon jacket completely removed from the true flow balloon.Based on the photos provided, the investigation is confirmed for peeling of the outer balloon jacket and sheath retraction problems.Conclusion: the investigation is confirmed for a longitudinal rupture on the barrel of the balloon, deflation issues, sheath retraction problems, and peeling of the outer jacket.The balloon rupture likely resulted in the inability to completely deflate the balloon, which lead to the sheath retraction problems and the peeling of the outer jacket.The current ifu (instructions for use) states "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." additionally, the ifu states to use a luer lock syringe/inflation device with manometer (50ml or larger).As a 30cc syringe was used with no pressure monitoring device it is possible that the balloon was over-pressurized, causing the balloon to rupture.However, the definitive root cause for the balloon rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current true flow balloon dilatation catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.Additional information: expiry date: date received by manufacturer; type of report - mdr; type of follow up; manufacturing date; (b)(4).Update: device evaluated; evaluation summary attached; device not evaluated code; (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.

Event Description

It was reported that during an aortic valvuloplasty, one of the eight balloons allegedly ruptured after four seconds of inflation using a 30cc syringe.There was no reported retraction issues.The balloon was replaced with a new aortic valve to complete the procedure.There was no reported patient injury.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Type of Device: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5798414
• MDR Text Key: 49665110
• Report Number: 2020394-2016-00646
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

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: 05/28/2017
• Device Catalogue Number: TF0243514
• Device Lot Number: GFAS2180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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: 81 YR