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

Catalog Number CQ75104

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Retraction Problem (1536); Device Operates Differently Than Expected (2913)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation 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 catheter allegedly did not deflate properly in an a/v fistula and allegedly was difficult to remove through the sheath; therefore, the catheter and the sheath were removed together as a single unit.Reportedly, another balloon catheter was used to complete the procedure.There was no reported 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 inspection: the sample was returned.The catheter was stretched and bunched throughout its length, likely indicating retraction issues.The distal end of the balloon was protruding from the distal end of the introducer sheath.The balloon was partially prolapsed over the distal tip.No other visual anomalies were identified on the device.The distal tip of the introducer sheath was observed to be flared, indicating retraction issues.Slight bunching was observed at the proximal end of the sheath.No other visual anomalies were identified to the sheath.Functional/performance evaluation: the catheter was advanced to expose the balloon past the customer's returned 7f introducer sheath.An attempt was made to inflate the balloon with water using an in-house inflation device; however, the balloon was unable to be inflated.The balloon was stripped and cut at the proximal cone to examine the inflation/deflation port.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; however, the glue bullet was still not visible.The catheter was sliced open in an attempt to locate the glue bullet.The glue bullet was found dislodged from the polyimide inside the outer catheter shaft.The glue bullet could not be measured due to it becoming dislodged from 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 investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to poor sample condition ( i.E.Glue bullet lodged in outer catheter).The investigation is confirmed for retraction problems, as the distal tip of the introducer sheath was flared and the device was returned inside of the sheath.The inability to fully deflate the balloon likely lead to the retraction issues.However, the root cause for the deflation issue is unknown.Labeling review: the conquest 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 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: 5304151
• MDR Text Key: 34332434
• Report Number: 2020394-2015-02028
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: CQ75104
• Device Lot Number: REZA0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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