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

Catalog Number TF0243514

Device Problems Peeled/Delaminated (1454); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records or no 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 procedure the balloon was allegedly difficult to remove through the 14fr sheath.Reportedly, the balloon was able to be removed from the sheath after multiple attempts.Another balloon was used to complete the procedure.There was no reported patient injury.

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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation; one introducer sheath was also returned with the device.A visual inspection found the outer fiber-based jacket to have been completely detached from the balloons and was not returned.Additionally, the outer parylene coating on the balloons was found to be peeling throughout the length of each balloon.The distal tip of the returned sheath was noted to be buckled.Therefore, based on the buckled sheath tip the investigation is confirmed for the reported retraction issue.The investigation is also confirmed for a detached outer jacket, and for peeled parylene.It is likely that the retraction issues contributed to the identified peeled parylene and detached outer fiber jacket.However, as the jacket was not returned with the device, a definitive root cause for the identified retraction issues could not be determined based on the available information.Labeling review: the current instructions for use (ifu) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation, or cause injury to the patient (such as vessel perforation).Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.In the very unlikely event of balloon burst or rupture, balloon could be more difficult to remove through the sheath and could require introducer sheath removal.Use of the true¿ flow valvuloplasty perfusion catheter: position the balloon within the relevant area of the aortic valve to be dilated, ensure the guidewire is in place, and while ensuring the balloon is held in a static position, inflate the balloon to a pressure not greater than rbp.Apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.If balloon does not appear to be fully deflated, ensure product is outside aortic valve in safe position for secondary inflation.Inflate slightly and deflate again to ensure complete deflation is achieved.While maintaining negative pressure and the position of the guidewire, withdraw deflated catheter over the guidewire and through the introducer sheath.Use of a gentle clockwise twisting motion ay be used to help facilitate catheter removal through the introducer sheath.If unusual resistance is met when attempting to withdraw balloon, position balloon in anatomical position in which it can be inflated safely.Inflate balloon and then deflate it.Balloon re-folding can be observed under fluoroscopy.Use of recommended contrast concentration will facilitate fluoroscopic visualization of balloon re-folding.

Event Description

It was reported that during an aortic valvuloplasty procedure the balloon was allegedly difficult to remove through the 14fr sheath.Reportedly, the balloon was able to be removed from the sheath after multiple attempts.Another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: TRUE FLOW DILATATION CATHETER
• Type of Device: VALVULOPLASTY BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7364379
• MDR Text Key: 103418695
• Report Number: 2020394-2018-00270
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741097676
• UDI-Public: (01)00801741097676
• Combination Product (y/n): N
• PMA/PMN Number: K152613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: TF0243514
• Device Lot Number: GFBQ3874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 120