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

Catalog Number CQ75124

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

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

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

No 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 that the pta balloon allegedly would not deflate in the iliac artery for approximately 34 to 35 minutes.It was further reported that additional medical intervention (a needle stick through the skin) was required to deflate the balloon.Reportedly, the balloon was able to be retracted without further incident once the balloon was deflated.Reportedly, another balloon was used to complete the procedure.There was no reported impact or consequence to the patient.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot meets all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the second complaint that has been reported for this corporate lot number 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 catheter was cut in half just distal to the strain relief.It is unknown why the catheter was cut in half, as it was not reported by the user.The edges of the cut catheter were examined under microscopic magnification (16x) and the cut was clean.No other anomalies were noted to the device at this time.Functional/performance evaluation: the cut portion of the catheter was connected to a touhy borst adapter.The touhy borst adapter was then connected to an inflation device.An attempt was made to inflate the balloon.The balloon was unable to be inflated, as water leaked out of the fibers of the balloon 5.5cm from the distal tip.The balloon fibers were then stripped and the site of the reported needle stick was identified 6.5cm from the distal tip.The balloon was cut with a scalpel near 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, the glue bullet was examined under microscopic magnification and the flat edge appeared to be perpendicular to the polyimide.The stepped portion of the shaft was examined under microscopic magnification and was observed to be slightly oval in shape.Dimensional evaluation: the acceptable range for the glue bullet od is 0.0638+/- 0.0010¿.The od of the glue bullet was measured, and found to be 0.0620".This measurement was not within the acceptable range.The acceptable range for the id of the stepped portion of the catheter shaft is 0.055 +/- 0.005¿.The id of the stepped portion was measured, and found to be 0.057".This measurement was within the acceptable range.The acceptable range for the od of the stepped portion of the catheter shaft is 0.072 +/- 0.002¿.The od of the stepped portion was measured, and found to be 0.074".This measurement was within the acceptable range.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.The investigation is inconclusive for deflation issues, as the balloon was unable to be functionally tested due to the poor sample condition (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.The evaluation found that the od of the glue bullet did not meet the minimum required specification of 0.0638", the glue bullet od was measured to be 0.0620".Additionally, the flat edge of the glue bullet was slanted.The root cause for the improperly formed glue bullet is manufacturing related and likely caused the reported deflation issues.Labeling review: the current ifu (instructions for use) states: - when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Use of the conquest pta dilatation catheter: - position the balloon relative to the lesion to be dilated, ensure the guidewire is in place and inflate the balloon to the appropriate pressure.- apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.- while maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over the wire through the introducer sheath.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.Potential adverse reactions: - vessel dissection, perforation, rupture, or spasm.

• Brand Name: CONQUEST PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 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 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5648064
• MDR Text Key: 45003572
• Report Number: 2020394-2016-00440
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYE2018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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: 79 YR
• Patient Weight: 61