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

Catalog Number CQ75124

Device Problems Deflation Problem (1149); Product Quality Problem (1506); Retraction Problem (1536)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/24/2015

Event Type  Injury  

Manufacturer Narrative

No device, no medical records or no medical images have been made available to the manufacturer.The lot number for the device has been provided.A review of the device history records is currently being performed.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 the pta balloon was allegedly unable to be deflated.It was further reported that the health care provider performed a percutaneous puncture of the balloon under echo in order deflate and remove the device.The device and sheath were allegedly removed as a single unit.Reportedly, the patient required hospitalization for 96 hours to monitor the puncture site.It was also reported that further intervention, placing of a prosthesis in the superior vena cava, occurred.There was no clinical consequence for the patient.

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.Visual inspection: the sample was returned.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as an 12mm x 4cm balloon.The catheter was stretched and bunched 9.5cm from the distal tip, likely indicating retraction issues.The balloon was received fully advanced through the introducer sheath.The distal end of the balloon was slightly bunched.No other anomalies were observed to the device at this time.The distal tip of the introducer sheath was observed to be flared, indicating retraction issues.No other anomalies were observed to the sheath.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issue.The balloon was retracted through the introducer sheath without issue.The balloon was then able to be advanced through an in-house 8fr introducer sheath without issue.An attempt was made to inflate the balloon with water using an in-house device.The balloon was unable to be inflated.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation port in an attempt to determine why the balloon would not deflate.The glue bullet was not in its correct location and was lodged inside the outer catheter shaft.The polyimide was pulled distally to remove the glue bullet from the outer catheter.The glue bullet was examined under a microscope and the flat edge of the glue bullet appeared to be perpendicular to the polyimide.It is unknown when the glue bullet became lodged inside the catheter shaft, as the stretching of the outer catheter could have contributed to the glue bullet lodging inside the catheter.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 device was returned within a 8fr introducer sheath.The investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to the glue bullet blocking the inflation/deflation port.The investigation is confirmed for a product quality issue, as the glue bullet was lodged in the outer catheter shaft and was blocking the inflation/deflation port.The investigation is confirmed for retraction problems, as the distal tip of the introducer sheath was flared and the outer catheter shaft was stretched.The root cause for the deflation issues is unknown.As the catheter was stretched and the stepped portion of the catheter shaft was damaged, it is possible that excessive force was exerted on the catheter and damaged the shaft, causing the glue bullet to become lodged.Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.(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.

• Brand Name: CONQUEST PTA BALLOON 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: 5395994
• MDR Text Key: 36980239
• Report Number: 2020394-2016-00133
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: CQ75124
• Device Lot Number: REZF1302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 69