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

Catalog Number RV8054

Device Problems Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.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 during the first inflation, in the right leg femoral artery, the pta balloon allegedly would not inflate.There was no reported retraction difficulty through the sheath and another pta balloon was used to complete the procedure.There was no reported patient injury.

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 only complaint that has been reported for this corporate lot number to date.Visual/microscopic inspection: the device was returned.The balloon appeared to be in its original folded configuration.No anomalies were noted to the returned device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an 0.035¿ guidewire, and it passed without issue.The inflation hub was connected to an inflation device, and an attempt was made to inflate the balloon with water.The balloon was unable to inflate.The catheter was cut in half just distal to the hub and a tuohy borst adapter was connected to the catheter and an inflation device.The balloon was inflated to nominal pressure (8 atm) without issue.The balloon was unable to be inflated to rbp (14 atm), as a proper seal could not be maintained with the tuohy borst adapter.The balloon was deflated without issue.The inflation hub that was connected to an inflation device and an attempt was made to pass water through the inflation lumen.Water did not pass through the inflation lumen.Further evaluation of the sample was performed by dissecting the hub to examine the inflation lumen.It was found that the inflation lumen was blocked by an unknown foreign material.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 complaint investigation is confirmed for inflation issues.The investigation is also confirmed for foreign material present in the device, as an unknown material was blocking the inflation lumen opening inside the hub.The origins of the foreign material found blocking the opening to the inflation lumen could not be determined.It is unlikely that the blockage is manufacturing related, as there are multiple manufacturing controls in place to prevent these types of issues.Based upon the available information, the definitive root cause for this event is unknown.Labeling review: the current rival 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: RIVAL 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5573579
• MDR Text Key: 43181841
• Report Number: 2020394-2016-00357
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052149
• 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: 12/09/2015

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: 07/31/2018
• Device Catalogue Number: RV8054
• Device Lot Number: GFZF3037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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: 64 YR