MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U4150222
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.
Event or Problem Description
It was reported that upon removal of the protective sleeve, the pta balloon allegedly detached.Another device was used to perform the procedure.There was no reported patient involvement.
Additional Manufacturer Narrative
H10: this supplemental emdr is being submitted to report the receipt of the lot number on 0208/2019.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.H11: d10, h3, h6 (method1, results1, conclusion1) 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.
Event or Problem Description
It was reported that upon removal of the protective sleeve, the pta balloon allegedly detached.Another device was used to perform the procedure.There was no reported patient involvement.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned.A visual inspection found the device was received in two separate segments with a complete catheter detachment of the guidewire lumen.Therefore, the investigation is confirmed for the reported detachment.It is likely that during removal of the balloon guard, excessive force was applied, resulting in the catheter detachment.However, the definitive root cause for the reported issue could not be determined based upon available information.Labeling review: the current ifu (instructions for use) states: dilatation catheter preparation: remove the balloon guard and stylet by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter.
Event or Problem Description
It was reported that upon removal of the protective sleeve, the pta balloon allegedly detached.Another device was used to perform the procedure.There was no reported patient involvement.

• Brand Name: ULTRAVERSE 014 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: 8261799
• Report Number: 2020394-2018-02335
• Device Sequence Number: 16452388
• Product Code: LIT
• UDI-Device Identifier: 00801741053474
• UDI-Public: (01)00801741053474
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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 Expiration Date: 09/30/2020
• Device Model Number: U4150222
• Device Catalogue Number: U4150222
• Device Lot Number: CMBX0181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 02/08/2019; 04/30/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/05/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1