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

Model Number	DF7007SC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2024).
Event or Problem Description
It was reported that during graft placement procedure, the graft allegedly torn.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: one distaflo graft was returned for evaluation.Gross visual evaluation was performed.The sample appeared to be bloody.It was noted the beads were dislodged from multiple sites throughout its length.The graft measures 33.5cm from end one to the other end.Sutures were noted on one end of the graft.The investigation is confirmed for the reported torn material, as sutures were noted on one end of the graft.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2024), g3.H11: section a through f ¿ the information provide 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 during graft placement procedure, the graft allegedly torn.There was no reported patient injury.

• Brand Name: DISTAFLO BYPASS GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10957796
• Report Number: 2020394-2020-20764
• Device Sequence Number: 11560691
• Product Code: DSY
• UDI-Device Identifier: 00801741023576
• UDI-Public: (01)00801741023576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: DF7007SC
• Device Catalogue Number: DF7007SC
• Device Lot Number: VTDU0459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other