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

Catalog Number CQ75124

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The facility rep stated that the device was available for evaluation.A sample return kit was sent to the facility and is pending return.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 was allegedly difficult to retract from the patient.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the device was returned with the device packaging and label.The balloon hub was returned, however, it is unclear when it was cut from the device.The balloon was previously inflated.The distal end of the balloon was slightly bunched, possibly indicating that the glue bullet was lodged in the catheter shaft.The device was returned within a damaged 9f introducer sheath.Part of the inner sheath coil was wrapped around the catheter shaft.No fiber disturbances were noted.No other anomalies were noted to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was tested and passed without issue.The balloon was unable to be inflated, as inflation luer was not returned with device.The balloon was cut with a scalpel near the inflation deflation ports.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.Additionally, the glue bullet did not have a flat edge.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.The investigation was inconclusive for inflation/deflation issues, as the balloon was unable to be inflated due to missing inflation luer.The investigation was confirmed for sheath retraction issues, based on the received condition of the device.The investigation was confirmed for a product quality issue.The device evaluation found the glue bullet lodged within the catheter shaft, blocking the inflation/deflation ports.The outer diameter of the glue bullet did not meet the minimum required specification.However, this may not be an accurate measurement, as the glue bullet may have been forced into the catheter shaft.Additionally, the bullet did not have a flat edge.The root cause for the glue bullet becoming lodged in the catheter shaft is possibly manufacturing related and likely caused the 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: additional intervention conquest pta dilatation catheter brochure: the recommended sheath size for this sized device is 8fr.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 was allegedly difficult to deflate after treatment in the svc and was subsequently difficult to retract through the sheath due to the residual fluid in the balloon.There was no reported patient injury.

• Brand Name: CONQUEST PTA BALLOON 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: 5980002
• MDR Text Key: 55718018
• Report Number: 2020394-2016-00907
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741063251
• UDI-Public: (01)00801741063251(17)171031(10)REYJ1940
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: CQ75124
• Device Lot Number: REYJ1940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2014
• 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 Age: 26 YR