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

Model Number	U4150322
Medical Device Problem Codes	Unraveled Material (1664); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo is provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2023).
Event or Problem Description
It was reported that prior to an angioplasty procedure the pta balloon material allegedly unraveled the procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
The file was reassessed for reportability and determined to be no longer reportable.Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was returned for evaluation.Two electronic photos were provided.The first photo shows outer pack with label, lot number and catalog number were verified.Second photo shows the balloon in clean condition and no kinks were noted.The tip of the balloon noted to be unfolded, based on the photos reviewed the reported device damaged issue can be confirmed for.One ultraverse 018 pta catheter was returned for evaluation.Visual evaluation was performed and the sample appeared to be clean.It was noted near the distal end the balloon had become un-pleated and the distal end appeared to be unfolded.Functional testing was performed using an in-house presto device the balloon successfully inflated with uniform shape and pressure, it deflated with no issue.Therefore the investigation is confirmed for the reported device damaged issue as the distal end of the balloon appeared to be unfolded.A definitive root cause for the reported device damaged prior to use 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: 07/2023.Section a through f ¿ the information provide 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 prior to an angioplasty procedure the pta balloon material allegedly unraveled upon initial removal of hoop.The procedure was completed using another device.There was no patient contact.

• 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: 10808063
• Report Number: 2020394-2020-20388
• Device Sequence Number: 14359983
• Product Code: LIT
• UDI-Device Identifier: 00801741053832
• UDI-Public: (01)00801741053832
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: U4150322
• Device Catalogue Number: U8130622
• Device Lot Number: CMEV0284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 04/12/2021
• 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