MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SOLO¿ FLEX HYBRID GUIDEWIRE; SOLO FLEX HYBRID GUIDEWIRES

Model Number	HW35FS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that there was flaking from the guidewire during use.No patient injury was reported.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error, as bard medical does not have regulatory reporting responsibility for oem products.
Event or Problem Description
It was reported that there was flaking from the guidewire during use.No patient injury was reported.

• Brand Name: BARD® SOLO¿ FLEX HYBRID GUIDEWIRE
• Common Device Name: SOLO FLEX HYBRID GUIDEWIRES
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6974219
• Report Number: 1018233-2017-05437
• Device Sequence Number: 13820435
• Product Code: EZB
• UDI-Device Identifier: 00816840020333
• UDI-Public: (01)00816840020333
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 06/29/2020
• Device Model Number: HW35FS
• Device Catalogue Number: HW35FS
• Device Lot Number: PL00251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1