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

Catalog Number CQ75104

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

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

Event Date 03/14/2016

Event Type  malfunction  

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 that the pta balloon allegedly could not be deflated at 18 atm.It was also reported that there was difficulty retracting the balloon through the sheath.Another pta balloon was used to successfully complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual inspection: the sample was returned.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as an 10mm x 4cm balloon.The balloon appeared to have been previously inflated.No other anomalies were observed to the device at this time.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issue.With the guidewire in place, the balloon was inserted through an in-house 7fr introducer sheath without issue.An attempt was made to inflate the balloon with water using an in-house inflation device.The balloon was inflated to rbp (24atm), and took the appropriate shape upon inflation.While manipulating the balloon, the balloon took 3 minutes and 19 seconds to fully deflate.The balloon was retracted from the introducer sheath without issue.Medical records review: as medical records were not provided, a review could not be performed.Image review: based on the image provided, the distal section of the pta angioplasty balloon was partially inflated, can be confirmed.Conclusion: the investigation is confirmed for deflation issues, as the balloon was slow to deflate.The investigation is confirmed for a product quality issue, as the inflation/deflation ports were not present on the catheter.The investigation is inconclusive for retraction problems, as the balloon was able to be retracted from the introducer sheath during functional testing, however the reported conditions of use could not be recreated (i.E.Balloon was manipulated in order to deflate balloon during functional testing).The root cause for the deflation issues was due to the inflation/deflation ports missing on the catheter.The root cause for the missing inflation/deflation ports is manufacturing related.The deflation issues likely lead to issues retracting the balloon through the introducer sheath.Labeling review: the current ifu (instructions for use) states: warnings: 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: 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.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 DILATATION CATHETER
• Type of Device: PTA DILATATION BALLOON 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: 5568698
• MDR Text Key: 42963733
• Report Number: 2020394-2016-00346
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

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: 06/30/2018
• Device Catalogue Number: CQ75104
• Device Lot Number: REZG0941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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 Age: 54 YR