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

Catalog Number	RV8074
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2016
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.
Event or Problem Description
It was reported that during an angioplasty procedure in the sfa the pta balloon allegedly had difficulty retracting through the sheath.Reportedly, a new guidewire and a new balloon were used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 7mm x 4cm balloon.No anomalies were observed to the device.Functional/performance evaluation: an attempt was made to retract the inserted guidewire, the guidewire was unable to be retracted.An attempt was made to advance the guidewire, the guidewire was unable to be advanced.With the guidewire stuck in place, the balloon was inserted through an in-house 6fr introducer sheath without issue.The inflation hub was connected to an in-house inflation device and an attempt was made to inflate the balloon with water.The balloon was inflated to rbp without issue.No leaks were observed on the balloon or the catheter shaft or the inflation hub.The balloon was deflated without issues.This test was performed twice, yielding the same results.The balloon was retracted from the introducer sheath without issue.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo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 sample was returned with a guidewire inserted.The investigation is unconfirmed for sheath related retraction issues, as the device was able to be advanced and retracted through an in-house introducer sheath without issue.However, the investigation is confirmed for guidewire related device-device incompatibility, as a guidewire was returned stuck inside the device and was unable to be retracted/advanced.The root cause could not be determined based upon available information.It is unknown whether the original guidewire and/or procedural issues contributed to the event.Labeling review: the current japan ifu (instructions for use) states: [warnings]: contents supplied sterile using ethylene oxide (eo).Non-pyrogenic.Do not use if sterile barrier is opened or damaged; to reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis; 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.]; do not exceed the prescribed rbp for each device.To prevent over pressurization, use of a pressure monitoring device is recommended.[balloon rupture may occur if the rbp rating is exceeded.]; careful attention must be paid to the dilatation of calcified lesions or tortuous anatomy.Method for use: do not reuse; do not resterilize.(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 in the sfa the pta balloon allegedly had difficulty retracting through the sheath.Reportedly, a new guidewire and a new balloon were used to complete the procedure.There was no reported patient injury.

• Brand Name: RIVAL 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: 6248279
• Report Number: 2020394-2016-01267
• Device Sequence Number: 10989927
• Product Code: DQY
• UDI-Device Identifier: 00801741063770
• UDI-Public: (01)00801741063770(17)190430(10)GFAQ2808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: RV8074
• Device Lot Number: GFAQ2808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 56