MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U35130515
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly ruptured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was conducted and it was determined that a device history record review was not required.Investigation summary: the investigation is inconclusive for the reported balloon rupture, as the device was not returned for evaluation.The definitive root cause for the reported balloon rupture could not be determined based on the available 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.H10: d4 (expiry date: 05/2023).H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

• Brand Name: ULTRAVERSE 035 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: 10712010
• Report Number: 2020394-2020-20199
• Device Sequence Number: 3281751
• Product Code: LIT
• UDI-Device Identifier: 00801741092725
• UDI-Public: (01)00801741092725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142261
• 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,Followup
• Report Date (Section B): 02/09/2021

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: U35130515
• Device Catalogue Number: U35130515
• Device Lot Number: CMET0335
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 03/09/2021
• 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