MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VALEO BALLOON EXPANDABLE; BALLOON EXPANDABLE STENT

Model Number	EV08562CD
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2020
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 for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2022).
Event or Problem Description
It was reported that prior to an angioplasty procedure, the inflation portion allegedly broke.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the inflation portion allegedly broke.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one valeo balloon has returned for evaluation.On the visual evaluation of the device, the device in two segment in which it consist of y-body and catheter which was still inside of the plastic tubing, balloon protector was still placed over the balloon and stent was still intact over the balloon.No other anomalies noted.No functional evaluation performed due to the condition of the sample returned.Therefore the reported detachment of device component is confirmed as the device returned in two segments.The definitive root cause for the reported detachment of device component could not be determined based upon 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.H10: d4 (expiry date: 01/2022),g4.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.

• Brand Name: VALEO BALLOON EXPANDABLE
• Common Device Name: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10552501
• Report Number: 2020394-2020-05698
• Device Sequence Number: 3539030
• Product Code: FGE
• UDI-Device Identifier: 00801741000867
• UDI-Public: (01)00801741000867
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: EV08562CD
• Device Catalogue Number: EV08562CD
• Device Lot Number: GFDY3027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1