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

Model Number	70T74TWC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 03/2024).Device pending return.
Event or Problem Description
It was reported some time post graft placement, granuloma formation was identified.Patient current status was unknown.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged torn material 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: b5, d4 (expiry date: 03/2024), g3, h6(method).H11: e1, h6(result, conclusion).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.
Event or Problem Description
It was reported that some time post graft placement, granuloma formation was identified.Patient underwent surgical excision to remove the granuloma.Patient current status was unknown.
Event or Problem Description
It was reported that some time post graft placement, granuloma formation was identified.Patient underwent surgical excision to remove the granuloma.Patient current status was unknown.
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: five sealed impra eptfe vascular grafts lot samples were returned for evaluation.All samples inner packaging trays were noted to be sealed, no anomalies were noted to the samples.Due to the nature of the complaint, there is no functional testing was performed.Therefore the investigation for the lot sample is inconclusive for the reported issue, the original reported device will remain inconclusive for the reported issue as they were not returned for evaluation.A definitive root cause for the alleged patient device interaction problem 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: 03/2024),.

• Brand Name: IMPRA CARBOFLO EPTFE VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFTS
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12493816
• Report Number: 2020394-2021-01746
• Device Sequence Number: 16988245
• Product Code: DYF
• UDI-Device Identifier: 00801741021664
• UDI-Public: (01)00801741021664
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K004012
• 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): 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70T74TWC
• Device Catalogue Number: 70T74TWC
• Device Lot Number: VTDQ0390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 11/12/2021; 01/10/2022
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/16/2021; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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