MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS

Catalog Number UNK CONQUEST 40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extravasation (1842)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not 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 post endovascular stent deployment, the delivery system allegedly became stuck on the covered stent during retraction; therefore, the stent within the vessel was further dilated with a pta balloon, creating room, and allowing the delivery system to be removed without incident. However, after the delivery system was removed, the patient reportedly experienced native vein extravasation proximal to the deployed stent; therefore, another stent was deployed stopping the bleeding and completing the procedure. There was no reported patient injury.

Manufacturer Narrative

Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed. Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed. 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 investigation is inconclusive, as the sample was not returned for evaluation. The definitive root cause 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 ifu (instructions for use) states: warnings: - to reduce the potential for stent or stent graft damage and/or vessel damage from the stent or stent graft, the diameter of the balloon should be no greater than the diameter of the stent or stent graft. Refer to the stent or stent graft ifu for safety information including the warnings, precautions and potential adverse effects regarding the use of balloon post dilatation. - 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. - 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. 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. 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 post endovascular stent deployment, the delivery system allegedly became stuck on the covered stent during retraction; therefore, the stent within the vessel was further dilated with a pta balloon, creating room, and allowing the delivery system to be removed without incident. However, after the delivery system was removed, the patient reportedly experienced native vein extravasation proximal to the deployed stent; therefore, another stent was deployed stopping the bleeding and completing the procedure. There was no reported patient injury.

• Brand Name: CONQUEST 40 PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6451389
• MDR Text Key: 71460706
• Report Number: 2020394-2017-00286
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK CONQUEST 40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/31/2017 Patient Sequence Number: 1