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

Catalog Number CQ7574

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 10/12/2015

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device has not been provided, a review of the device history records could not be 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 the pta balloon allegedly would not deflate after the first inflation in an av fistula in the sfa.It was further reported that a needle stick through the skin was made to deflate the balloon.Allegedly, there was some retraction difficulty through the sheath.Reportedly, another pta balloon catheter was used to complete the procedure.There was no reported impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: the sample was returned.The balloon was slightly prolapsed near the distal tip, likely indicating retraction issues.The distal end of the balloon was protruding from the distal end of the sheath.The catheter was bunched just proximal to the proximal balloon glue joint.The catheter was stretched 9.8cm and 13.9cm from the distal tip.The stretching and bunching of the catheter likely indicates that there were issues retracting the balloon through the introducer sheath.No other anomalies were observed to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was tested, and it passed without issue.An attempt was made to inflate the balloon with water and 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 inflate.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, the glue bullet was examined under a microscope and the flat edge of the bullet was slanted and not perpendicular to the polyimide.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 functionally tested due to the glue bullet blocking the inflation/deflation port.The investigation is confirmed for a product quality issue, as the flat edge of the glue bullet was slanted.The investigation is also confirmed for retraction problems based on the condition of the returned samples (i.E.Catheter stretched and balloon bunched).The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.The flat edge of the glue bullet was slanted and not perpendicular to the polyimide.The root cause for the glue bullet becoming lodged in the catheter shaft is manufacturing related and likely caused the deflation issues, which lead to the retraction issues.Labeling review: the current conquest pta dilatation catheter ifu (instructions for use) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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: 5203167
• MDR Text Key: 30459070
• Report Number: 2020394-2015-01803
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

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 Catalogue Number: CQ7574
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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