MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VALEO; BALLOON EXPANDABLE BILIARY STENT

Catalog Number	EV09361CD
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent placement procedure, the packaging allegedly contained different sized product.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2025).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 stent placement procedure in the common iliac artery, the packaging allegedly contained different sized product.The procedure was completed using same device.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.Investigation summary: the sample was returned for evaluation alongside the outer packaging box.The outer packaging box indicated the given lot number and product catalog number.The product labeling specified a 9x36mm stent with an 80 cm shaft length.The product received had the indications printed on the hub of a 9x36mm stent with a 120 cm shaft length.The device was returned to manufacturing where it was determined the device was a 120 cm shaft, and the packaging hoop returned was for a 120 cm shaft device.Sales information was pulled for the reported complaint facility.The facility has no purchase history of a 9x36 mm stent on a 120 cm length catheter shaft.The facility has only purchased the 9x36 mm stents on the 80 cm shaft length.The product had not been through the returned goods process.Therefore, it is unknown how the facility would have obtained the 120 cm catheter length device with the 9x36 mm stent that was returned as the reported complaint device without a mix up of the product in the packaging.Therefore, the investigation is confirmed for the reported product mix up, as the user returned a 120 cm length shaft device despite no sales history of purchasing this size product.The likely root cause of the failure was determined to be a manufacturing related mix up.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.The instructions for use states: precautions: inspect the valeo® balloon expandable biliary stent and delivery system prior to use to verify that the stent has not been damaged during shipment or handling and that the device dimensions are suitable for the specific procedure.Do not attempt to remove or adjust the stent on the delivery system.The product labeling contained valid information for the given lot number and product catalog number, but did not match the specifications of the product inside the packaging box.H10: b5, d4 (expiration date: 07/2025), g3 h11: 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.H3 other text : see h10.

• Brand Name: VALEO
• Common Device Name: BALLOON EXPANDABLE BILIARY STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18577361
• Report Number: 2020394-2024-00110
• Device Sequence Number: 9163305
• Product Code: FGE
• UDI-Device Identifier: 00801741000911
• UDI-Public: (01)00801741000911
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052132
• 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
• Report Date (Section B): 04/15/2024

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: EV09361CD
• Device Lot Number: GFHT2151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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: Male