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

Catalog Number CQ75124

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

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

Event Date 10/13/2015

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 an angioplasty procedure, a pta balloon allegedly would not deflate after the second inflation in the cephalic arch while treating in-stent restenosis.The health care provider (hcp) reported guided fluoroscopy was used to advance a needle percutaneously to successfully perforate the pta balloon.The hcp further reported the device was allegedly removed in its entirety, with difficulty, through the sheath.Another pta balloon was reportedly used to complete the procedure, and another stent was placed as intended.There was no reported known impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Visual/microscopic inspection: 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 distal end of the balloon was protruding out the distal end of the introducer sheath.The distal balloon material was bunched in appearance.The distal tip of the introducer sheath was observed to be flared, indicating retraction issues.The proximal end of the sheath was slightly bunched in appearance.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 unable to be retracted through the introducer sheath.The balloon was able to be advanced through the introducer sheath without issue.An inflation device was connected to the inflation hub.The balloon was unable to be inflated.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation ports.After opening the balloon, no anomalies were noted to the inflation/deflation ports.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/image/photo review: no medical records or medical images have been made available to the manufacturer.Conclusion: the device was returned.The investigation is confirmed for retraction issues as the balloon was returned within the customer's introducer sheath and the distal end of the introducer sheath was flared.The investigation is inconclusive for deflation issues, as the balloon was unable to be inflated due to the glue bullet being lodged in the outer catheter.The investigation is confirmed for a product quality issue, as the od of the glue bullet did not meet the minimum required specification.Additionally, the flat edge of the glue bullet was slanted.The evaluation found the glue bullet was lodged within the catheter shaft, blocking the inflation/deflation ports.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 conquest pta instructions for use (ifu) 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 DILATATON 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: 5210720
• MDR Text Key: 30729509
• Report Number: 2020394-2015-01811
• 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: Initial,Followup
• Report Date: 10/14/2015

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: CQ75124
• Device Lot Number: REZF0232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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: 49 YR
• Patient Weight: 75