MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. JAVID SHUNT; CAROTID SHUNT

Model Number 007714

Device Problems Nonstandard Device (1420); Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2025).

Event Description

It was reported that during carotid bypass procedure, the clamp holding the vessel and the shunt in place allegedly slid of the shunt.It was further reported that the device allegedly had a nonstandard appearance.There was no reported patient injury.

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; however, a manufacturing review was performed to verify manufacturing records as the user reported a device feature appeared smaller than normal.The lot met all release criteria.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 could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.Directions for use: how supplied/stored: bard® carotid bypass shunts are supplied sterile, unless package is damaged or opened.Single use.Do not resterilize.Bard® carotid bypass shunts are single-pouched and are supplied multiple pouches per box.Important: there are various techniques used in placing and affixing carotid bypass shunts.These shunts should be used only by qualified physicians thoroughly familiar with endarterectomy and patch-graft angioplasty techniques.Carotid bypass shunts are influenced by three significant factors: 1.The size, configuration and disease state of the artery.2.The design and dimensions of the shunt.3.The stabilization technique to hold the shunt in place.Stabilization can be accomplished by many techniques, including vessel loops, umbilical-type tapes, heavy ligatures, tourniquets, or surgical clamps.Surgical clamps should be appropriate in size and design for the shunt chosen.Warning: when there is an incompatibility between the stabilizing technique, the artery and the shunt, slippage can occur.In order to avoid slippage and/or vessel damage or disruption when the clamp technique is utilized, users should ensure that the clamps they employ are compatible in size and design with the particular shunt they intend to use.Suggested insertion techniques: non t-shaped shunts.The carotid arteries should be isolated, tourniquet loops placed, and the arterial incision made.The proper size shunt must be chosen, determined at the time of surgery, based on the surgeon¿s experience and training.Forcing a shunt that is too large into an artery may cause vessel disruption.Insert the shunt into the artery.Care should be taken not to dislodge plaque, clot, or to raise intimal flaps.The bypass shunt is held in place by tension on the tourniquet loops.The endarterectomy is then performed.When the endarterectomy is completed, using standard cardiovascular techniques, which may include patch-graft angioplasty, the shunt is removed and the incision is closed.H10: d4 (expiry date: 07/2025).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.H3 other text : device not returned.

Event Description

It was reported that during carotid bypass procedure, the clamp holding the vessel and shunt allegedly slid of the shunt.It was further reported that the device allegedly had a nonstandard appearance.There was no reported patient injury.

• Brand Name: JAVID SHUNT
• Type of Device: CAROTID SHUNT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11479294
• MDR Text Key: 244720326
• Report Number: 2020394-2021-00530
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00801741090110
• UDI-Public: (01)00801741090110
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 007714
• Device Catalogue Number: 007714
• Device Lot Number: HUEU1824
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other