MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER IQ ULTRASONIC; RECANALIZATION CATHETER

Model Number XCTO146

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a recanalization procedure, the tip was allegedly defective.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.However, a photo was provided for review.The investigation of the reported event is currently underway.Expiry date: 06/2023.

Event Description

It was reported that during preparation of a recanalization procedure, the tip was allegedly defective.The procedure was completed by using another device.There was no patient contact.

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 crosser iq ultrasonic device was returned for evaluation.It was observed the distal tip was detached from the inner core wire and not returned.A tear on the catheter beneath the marker band exposed the inner core wire.Therefore the investigation is confirmed for the detachment of the device or device component as the distal tip was detached.Based on the sample analysis, the reported deformation was noted to be a tear of the catheter therefore the material torn issue is confirmed.One electronic photo was also provided and reviewed.The photo shows the distal tip of the catheter.The tip was noted to be detached.The catheter was noted to be torn below the marker band.Therefore the investigation is confirmed for the tip detachment and material torn issue.A definitive root cause for the identified detachment of device or device component and identified material torn issue could not be determined based upon the provided information.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.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.

• Brand Name: CROSSER IQ ULTRASONIC
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 15758152
• MDR Text Key: 304545030
• Report Number: 2020394-2022-00884
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XCTO146
• Device Catalogue Number: XCTO146
• Device Lot Number: GFGS1746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1