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

Catalog Number CQ75104

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2015

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 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 during a tips procedure, a pta balloon would not deflate after the initial inflation in a portal hepatic shunt.The health care provider reported the balloon was inflated to 15 atms, and inflation/deflation manipulation was performed in an attempt to deflate the balloon, but was unsuccessful.The hcp further reported guided fluoroscopy was used to advance a needle percutaneously to successfully perforate the pta balloon.It was further reported that the device was removed in its entirety, without difficulty, through the sheath.Another pta balloon was reportedly used to complete the procedure.There was no known impact or consequence to the patient.

Manufacturer Narrative

The investigation of the reported event is currently underway.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual 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 an 10mm x 4cm balloon.No anomalies were noted to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issue.An attempt was made to inflate the balloon with water using an in-house device.The balloon leaked during inflation, likely due to the needle stick that the user used to deflate the balloon.The balloon was stripped of its fiber and the location of the reported needle stick was found 6.5cm from the distal tip.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation port.Upon removing the balloon, it was noted that 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.Upon removal, it appeared that the diameter of the glue bullet was too small, causing it to become lodged inside the outer catheter shaft.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is inconclusive for deflation issues, as the balloon was unable to be inflated due to the condition in which the sample was returned (i.E.Needle stick).The investigation is confirmed for a product quality issue, as the od of the glue bullet did not meet the minimum required specification, causing the glue bullet to become lodged within the outer catheter shaft.The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.The od of the glue bullet did not meet the minimum required specification of 0.0608", the glue bullet was measured to be 0.0598".The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the inflation/deflation issues.Labeling review: the current conquest pta dilatation catheter 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 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: 5134561
• MDR Text Key: 27832049
• Report Number: 2020394-2015-01671
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: CQ75104
• Device Lot Number: REZE1173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2015; 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2015
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 102