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	10/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is still pending.The investigation of the reported event is currently underway.(expiry date: 04/2021).
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon allegedly detached.Another device was used to complete the procedure.There was no reported patient involvement.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted on the dhr, mrb, receiving inspection, internal rejects history, manufacturing controls and fmeas.The manufacturing review did not indicated any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was returned for evaluation.A visual inspection found the balloon detached at the proximal balloon joint.Additionally the inner lumen was stretched and detached.Therefore, the investigation is confirmed for both balloon and catheter detachment, as well as for retraction issues.The inner lumen was inspected and the proximal marker band was noted to be detached and not returned; the distal marker band was intact on the inner lumen.Therefore, the investigation is confirmed for a detached marker band.Stretching was noted in the inner lumen, indicating that force was applied to the returned device.It is likely that this applied force resulted in the identified detachments.However, the definitive root cause for the identified issues could not be determined based upon the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the pta balloon allegedly detached.Another device was used to complete 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: 8091245
• Report Number: 2020394-2018-02101
• Device Sequence Number: 11127598
• Product Code: LIT
• UDI-Device Identifier: 00801741053474
• UDI-Public: (01)00801741053474
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• 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): 03/22/2019

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 Model Number: U4150222
• Device Catalogue Number: U4150222
• Device Lot Number: CMCS0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1