MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® HYDRO-GLIDE¿ GUIDEWIRE

Catalog Number	145FS38
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
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.H11: section a through f - the information provided 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 hydrophilic film coating came off in the patient.Almost like a snakeskin.They opened another wire.Per follow-up information received on 10apr2024, it was reported that there were a total of 29 wires pulled off the shelf after the incident with the reported wire that was flaking.That particular wire was discarded.No patient harm was reported.Customer has the remaining 29 that will be sent in for sample.
Event or Problem Description
It was reported that hydrophilic film coating came off in the patient.Almost like a snakeskin.They opened another wire.Per follow-up information received on 10apr2024, it was reported that there were a total of 29 wires pulled off the shelf after the incident with the reported wire that was flaking.That particular wire was discarded.No patient harm was reported.Customer has the remaining 29 that will be sent in for sample.Per sample received on 30apr2024, the customer returned six additional lot numbers for (batch#gfhw0335), (batch#gfhv2176, (batch#gfhx1239), (batch# gfhx1243), (batch#gfgr2107) and (batch#gfgr2531).
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 6 guidewires in unopened original packaging, no flaking noted in any of the 6, reported event was unconfirmed.The device is considered within specification and the reported event is considered unconfirmed.No root cause could be found because the reported event was unconfirmed.A dhr is not required since the reported failure was unconfirmed.The reported event is unconfirmed a labeling review is not required.H11: section a through f - the information provided 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.

• Brand Name: BARD® HYDRO-GLIDE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19132813
• Report Number: 1018233-2024-02179
• Device Sequence Number: 11926817
• Product Code: EZB
• UDI-Device Identifier: 00801741053269
• UDI-Public: (01)00801741053269
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Catalogue Number: 145FS38
• Device Lot Number: GFGT0251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown