MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PERIPHERAL VASCULAR SHEATH TUNNELER; SURGICAL OTHER

Catalog Number	PVT1000
Medical Device Problem Codes	Material Erosion (1214); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiration date: 02/2027) 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 during a surgical graft placement procedure, after sterilization, some materials were allegedly found to be dissolved from the set.There was no reported patient injury.
Event or Problem Description
It was reported that during a surgical graft placement procedure, after sterilization, some materials were allegedly found to be dissolved from the set.It was further reported that they saw black particles on the graft prothesis after they put it inside the tunneler.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one complete pv sheath tunneler set was received for evaluation.Upon visual evaluation, all components of the kit appeared to be present.The samples appeared to be clean.Therefore, the investigation is unconfirmed for the reported device contamination with chemical or other material and material erosion as all kit components were present and all appeared to be clean.A definitive root cause for the alleged device contamination with chemical or other material and material erosion could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: d2b (mzy; kct), d4 (unique identifier (udi) #), h6 (method, result, conclusion).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: PERIPHERAL VASCULAR SHEATH TUNNELER
• Common Device Name: SURGICAL OTHER
• 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: 19825523
• Report Number: 2020394-2024-01106
• Device Sequence Number: 8709484
• Product Code: KCT
• UDI-Device Identifier: 00801741090257
• UDI-Public: (01)00801741090257(17)270224(10)VTGN0274
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042062
• 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
• Report Date (Section B): 11/21/2024

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: PVT1000
• Device Lot Number: VTGN0274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 11/25/2024
• 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
• Patient Sex: Unknown