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

Model Number U420048RX

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

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 angioplasty procedure of a vein graft in the left posterior tibial, the pta balloon allegedly ruptured at 8atm.There was no reported retraction issues.The pta balloon was exchanged over the guidewire for another that 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 investigation is inconclusive for the reported rupture, as the device was not returned for evaluation.The definitive root cause for the reported rupture could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu (instructions for use) 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 or catheter breakage, catheter kink, or balloon separation.If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter 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 introducer sheath/guide catheter as a single unit.Do not exceed the rated burst pressure.To prevent over pressurization, use of a pressure monitoring device is recommended.Balloon rupture may occur if the rbp rating is exceeded.

Event Description

It was reported that during an angioplasty procedure of a vein graft in the left posterior tibial, the pta balloon allegedly ruptured at 8atm.There was no reported retraction issues.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

After further review of the additional event details provided, the event suggests an uncomplicated balloon rupture.This event was reassessed and determined to be not mdr reportable.However, an initial mdr has already been submitted; therefore, the purpose of this supplemental report is to document the change in reportability classification.

Event Description

It was reported that during an angioplasty procedure of a vein graft in the left posterior tibial, the pta balloon allegedly ruptured at 8atm.There was no reported retraction issues, no detachment of balloon material, and no vessel damage.The pta balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA 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: 7272964
• MDR Text Key: 100260688
• Report Number: 2020394-2018-00106
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741057533
• UDI-Public: (01)00801741057533
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: U420048RX
• Device Catalogue Number: U420048RX
• Device Lot Number: CMBU0366
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• 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: 63 YR
• Patient Weight: 142