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

Catalog Number	VA8064R
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly would not inflate.It was further reported that upon retraction from the patient, the health care provider attempted to inflate the balloon again and it was able to be inflated slightly; however, it was then unable to be deflated.Another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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/microscopic inspection: the balloon size printed on the balloon hub of the catheter identified the returned sample as a 6 mm x 4 cm balloon.No anomalies were noted.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035¿ guidewire, and it passed without issues.The inflation hub was connected to a in-house inflation device.An attempt was made to inflate the balloon with water.The balloon was able to fully inflate, with some difficulties.An attempt was then made to deflate the balloon, the balloon was unable to deflate.The balloon was cut at the proximal cone to examine the inflation/deflation ports.After opening the balloon, it was noted that the glue bullet was not lodged within the shaft.Both inflation/deflation port holes were examined.One of the inflation/deflation ports was completely glued over by the balloon.The other port hole was not glued over by the balloon.No further functional testing could be performed due to the balloon being cut open.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 confirmed for inflation and deflation issues, as it was identified that one of the inflation/deflation port holes was completely glued over by the balloon of the device.Per the evaluation results, an inflation/deflation port was completely glued over by the proximal end of the balloon.It is likely the glued over and blocked inflation/deflation port contributed to the reported inflation/deflation issues.However, the root cause for the blocked inflation/deflation port is unknown.This event has been confirmed as supplier related.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.Precautions: use the recommended balloon inflation medium (50% contrast medium/50% sterile saline solution).Never use air or other gaseous medium to inflate the balloon.If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Use of the v access pta balloon dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy.(b)(4).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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly would not inflate.It was further reported that upon retraction from the patient, the health care provider attempted to inflate the balloon again and it was able to be inflated slightly; however, it was then unable to be deflated.Another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: VACCESS PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6327519
• Report Number: 2020394-2017-00060
• Device Sequence Number: 1081421
• Product Code: DQY
• UDI-Device Identifier: 00801741059872
• UDI-Public: (01)00801741059872(17)191004(10)93WA0073
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2019
• Device Catalogue Number: VA8064R
• Device Lot Number: 93WA0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR