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

Model Number	U357564
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
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.The investigation of the reported event is currently underway.(expiry date: 03/2023).
Event or Problem Description
It was reported that during a procedure through the cephalic vein to treat circuit stenosis, the tip of the balloon allegedly separated from the device.The separated tip was snared and retrieved.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 035 pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody and distal tip of the balloon was completely detached from the catheter and not returned for evaluation.The balloon was noted to have a completely circumferential rupture and the marker bands are still intact with the catheter.Microscopic observation was performed to observe all the anomalies.No other functional evaluation performed due to the condition of the device.Therefore, the investigation is confirmed for the reported detachment of device as the distal tip of the device got detached from the catheter.The investigation also confirmed for the identified balloon rupture as a complete circumferential rupture were noted to the balloon which returned for evaluation.A definitive root cause for the alleged detachment of device and identified balloon rupture 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.H10: d4 (expiry date: 03/2023), g3.H11: h6 (result, conclusion).H11: 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 during a procedure through the cephalic vein to treat circuit stenosis, the tip of the balloon allegedly separated from the device.The separated tip was snared and retrieved.The procedure was completed using another device.There was no reported patient injury.

• 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: 11419371
• Report Number: 2020394-2021-00443
• Device Sequence Number: 16954962
• Product Code: LIT
• UDI-Device Identifier: 00801741092954
• UDI-Public: (01)00801741092954
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• 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): 04/15/2021

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: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMER0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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