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

Model Number	U42003H20RX
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiration date: 01/2024).
Event or Problem Description
It was reported that during an angioplasty procedure for right lower extremity stenosis in posterior tibial, while trying to remove the pta balloon, the wire and the balloon became allegedly stuck inside the sheath.It was further reported that another wire was inserted to keep the access and pulled out the balloon, wire and the sheath.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse rx pta dilatation catheter loaded onto an unknown guidewire and unknown introducer sheath was returned for evaluation in which the distal tip of the sheath was buckled.The catheter shaft had a tear at the hypo tube in which the guide wire was protruding out from it.The catheter and the balloon still noted to be loaded into the sheath.No other specific anomalies were noted during the visual evaluation.During functional testing, the balloon was removed from the returned sheath with slight resistance and the loaded guide wire was also noted to be removed from the hypo tube tear of the catheter.Upon the removal the balloon was inadvertently bunched at the proximal end of the balloon.Although during the functional testing both returned guide wire and sheath was removed, the catheter was noted to be loaded with these guide wire and sheath and returned to evaluation.Hence, the investigation is confirmed for the reported sheath removal issue and identified guide wire removal issue.The investigation is also confirmed for the identified catheter shaft tear as the returned catheter contains the tear at the hypo tube in which the guide wire was protruding out it.A definitive root cause for the reported sheath removal issue, identified guide wire removal issue and identified catheter shaft tear could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that during an angioplasty procedure in the distal posterior tibial artery, the pta balloon and the guidewire allegedly got stuck inside the sheath.It was further reported that another guidewire was inserted to keep the access and the balloon, guidewire and sheath were removed together as one unit.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16492839
• Report Number: 2020394-2023-00141
• Device Sequence Number: 6374544
• Product Code: LIT
• UDI-Device Identifier: 00801741057328
• UDI-Public: (01)00801741057328
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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 Model Number: U42003H20RX
• Device Catalogue Number: U42003H20RX
• Device Lot Number: CMFP0368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 130 KG