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

Catalog Number CQF7598

Device Problems Retraction Problem (1536); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

No 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 a pta balloon dilation catheter allegedly ruptured upon first inflation at 30atm.Allegedly, there was difficulty retracting the balloon through the sheath.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the device was returned.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 9mm x 8cm balloon.A partial circumferential rupture was noted to the fiber portion of the balloon, approximately 6.8cm from the distal tip.The polyimide was visible at the location of the rupture.No other anomalies were noted to the device at this time.Functional/performance evaluation: the balloon fibers were then stripped and a complete circumferential rupture to the base balloon was observed 6.5cm from the distal tip.No further functional testing could be performed.Conclusion: the investigation is confirmed for a complete circumferential balloon rupture to the base balloon material.The investigation is inconclusive for retraction issues, as sheath compatibility testing could not be performed due to the poor sample condition (i.E.Torn balloon fibers due to circumferential rupture).Per the reported event details, the balloon was inflated within a stent.It is unknown if the stent contributed to the balloon rupture.It is likely that the balloon rupture contributed to the difficulties retracting the balloon through the introducer sheath.However, based upon the available information, the definitive root cause could not be determined.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.- 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.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 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 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5314926
• MDR Text Key: 34608270
• Report Number: 2020394-2015-02041
• Device Sequence Number: 1
• Product Code: DQY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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: 06/30/2018
• Device Catalogue Number: CQF7598
• Device Lot Number: REZG0441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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: 57 YR
• Patient Weight: 130