MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U81502H15
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
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 018 pta device was returned for evaluation.Visual evaluation was performed, sample appeared to be bloody and bunching was noted throughout the inner guidewire lumen.During evaluation circumferential break was noted on the inner guidewire lumen.Functional testing could not be performed.However the investigation is confirmed for the reported device incompatibility issue as bunching was noted on inner guidewire lumen.The investigation is also confirmed for break issue as circumferential break was noted during visual evaluation.A definitive root cause for the reported device incompatibility and identified break issues could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 05/2022).
Event or Problem Description
It was reported that during an angioplasty procedure through right femoral artery for the treatment of atherosclerotic occlusion, the pta balloon allegedly unable to pass through guide wire.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE 018 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: 11699407
• Report Number: 2020394-2021-00895
• Device Sequence Number: 11646570
• Product Code: LIT
• UDI-Device Identifier: 00801741064814
• UDI-Public: (01)00801741064814
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121856
• 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): 03/26/2021

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: U81502H15
• Device Catalogue Number: U81502H15
• Device Lot Number: CMDT0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 58