MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VISILOC INTRODUCER SET; BIOPSY INSTRUMENT

Catalog Number	ECMRINTLOC
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
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 (expiry date: 04/2024).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.
Event or Problem Description
It was reported that prior to a biopsy procedure, ink was allegedly noticed which made it appeared contaminated.There was no patient contact.
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 opened 10g visiloc mri introducer set was returned for evaluation.On visual evaluation, visiloc introducer set was received with protective tubing and appeared to be clean.The obturator was received in two and black residue was observed in the tray.On microscopic observations, a circumferential break was noted to the obturator, partial liquid was noted to be missing within the obturator.No other anomalies were noted.Further functional testing was not performed, due to the condition of the device returned.Therefore, the investigation is confirmed for the identified break issue as a circumferential break was noted to the obturator.However, the investigation is kept as inconclusive for the reported device contamination issue as the identified break issue contributed the leak in the obturator.A definitive root cause for the alleged device contamination issue is due to the identified break issue noted in the obturator.However, the definite root cause for the identified break issue 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.H10: d4 expiry date: 04/2024.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 prior to a biopsy procedure, ink was allegedly noticed which made it appeared contaminated.There was no patient contact.
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 opened 10g visiloc mri introducer set was returned for evaluation.On visual evaluation, visiloc introducer set was received with protective tubing and appeared to be clean.The obturator was received in two and black residue was observed in the tray.On microscopic observations, a circumferential break was noted to the obturator, partial liquid was noted to be missing within the obturator.No other anomalies were noted.Further functional testing was not performed, due to the condition of the device returned.Therefore, the investigation is confirmed for the identified break issue as a circumferential break was noted to the obturator.However, the investigation is unconfirmed for the reported device contamination issue as the black liquid noticed is the liquid used within the obturator (the liquid turns black when exposed to oxygen) and not foreign to the device.The break observed in the obturator, which caused fluids inside to leak and turn black when exposed to oxygen, is a clear primary cause of the reported device contamination problem.However, the definite root cause for the identified break issue 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: 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 prior to a biopsy procedure, ink was allegedly noticed which made it appeared contaminated.There was no patient contact.

• Brand Name: VISILOC INTRODUCER SET
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19102513
• Report Number: 2020394-2024-00491
• Device Sequence Number: 17977899
• Product Code: KNW
• UDI-Device Identifier: 00801741086229
• UDI-Public: (01)00801741086229(11)231031(17)240401(10)VTHX0529
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161805
• 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,Followup
• Report Date (Section B): 10/08/2024

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 Expiration Date: 04/01/2024
• Device Catalogue Number: ECMRINTLOC
• Device Lot Number: VTHX0529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 10/08/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 08/26/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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