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

Catalog Number	RV8044
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a retrospective review of events that occurred in (b)(6) and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable.Manufacturing review: a manufacturing review was performed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: two electronic photos were reviewed by field assurance engineer.The first photo shows the device coiled up on brown paper towels.The balloon appears to be deflated and no anomalies were noted to the length of the device.The second photo is of just the balloon; the balloon appears to have been previously inflated.The balloon is curved starting at the proximal end of the balloon, however no signs of retraction issues were noted.Therefore, based on the photo review, the reported issues could not be confirmed.Conclusion: the investigation is inconclusive for the reported issue, as the photo review could not confirm a retraction issue and the sample was not returned for full functional evaluation of the device.The definitive root cause for the reported retraction issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.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.Do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon.If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter, introducer sheath and guidewire (as necessary) as a single unit.Use of the rival pta dilatation catheter: while maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the sheath and 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.
Event or Problem Description
It was reported that when removing the balloon catheter with the balloon inflated, the catheter allegedly became stuck in the sheath.There was no reported patient injury.

• Brand Name: RIVAL PTA 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: 6733828
• Report Number: 2020394-2017-00838
• Device Sequence Number: 1161334
• Product Code: DQY
• UDI-Device Identifier: 00801741063350
• UDI-Public: (01)00801741063350
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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: 10/31/2017
• Device Catalogue Number: RV8044
• Device Lot Number: GFYJ0683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2016
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1