MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	U42002H30RX
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The facility rep stated that the device was available for evaluation.A sample return kit was sent to the facility and is pending return.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 of a calcified lesion in the peroneal artery, the pta balloon allegedly detached from the catheter upon removal through the 6fr sheath after the second inflation/deflation attempt.It was further reported that the health care provider decided to leave the detached balloon segment in situ as there was no potential health hazard to the patient.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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.This is the only complaint reported to date for this lot number and failure mode.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.Per the reported event details, the patient vessel was calcified.Therefore, it is possible that patient issues contributed to the reported issue.The definitive root cause for the reported detachment could not be determined based upon available information.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 or catheter breakage, catheter kink, or balloon separation.Potential adverse reactions: additional intervention (b)(4).
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified lesion in the peroneal artery, the pta balloon allegedly detached from the catheter upon removal through the 6fr sheath after the second inflation/deflation attempt.It was further reported that the health care provider decided to leave the detached balloon segment in situ as there was no potential health hazard to the patient.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6828208
• Report Number: 2020394-2017-01039
• Device Sequence Number: 1521997
• Product Code: LIT
• UDI-Device Identifier: 00801741056727
• UDI-Public: (01)00801741056727
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• 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): 10/23/2017

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: 02/28/2018
• Device Model Number: U42002H30RX
• Device Catalogue Number: U42002H30RX
• Device Lot Number: 50118960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 62