MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO; EPTFE VASCULAR GRAFT

Model Number	F5008TWSC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon removal of c-arm after surgical graft implantation procedure in external iliac artery, prosthesis was allegedly torn.It was further reported that torn part was sutured to continue the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2024).
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Three photos were provided and reviewed.The three photos shows the carboflo which is being sutured by the surgeon in the place of the teared carboflo material.Hence, based on the photo, the reported material split, cut or torn issue can be confirmed.Therefore the investigation is confirmed for the reported material split, cut or torn issue.A definitive root cause for the reported material split, cut or torn issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 09/2024), device not returned.
Event or Problem Description
It was reported that upon removal of c-arm after surgical graft implantation procedure in external iliac artery, prosthesis was allegedly torn.It was further reported that torn part was sutured to continue the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that upon removal of c-arm after surgical graft implantation procedure in external iliac artery, prosthesis was allegedly torn.It was further reported that torn part was sutured to continue the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary:the physical device was not returned for evaluation.Three photos were provided and reviewed.The three photos shows the carboflo which is being sutured.However, the suturing is seen, there is no clear evidence of tear.Hence, the reported material tear issue cannot be confirmed.Therefore, the investigation is inconclusive for the reported material split, cut or torn issue.A definitive root cause for the reported material split, cut or torn issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 09/2024).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: CARBOFLO
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16331508
• Report Number: 2020394-2023-00055
• Device Sequence Number: 17840015
• Product Code: DSY
• UDI-Device Identifier: 00801741021565
• UDI-Public: (01)00801741021565
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2023

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: F5008TWSC
• Device Catalogue Number: F5008TWSC
• Device Lot Number: VTDW0243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/21/2023; 03/30/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/12/2023; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown