MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER CTO RECANALIZATION CATHETERS

Model Number CRUS6106

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  Injury  

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.The investigation of the reported event is currently underway.(expiration date: 10/2022).

Event Description

It was reported that during a recanalization procedure, the tip of the catheter allegedly detached.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.Investigation summary: one 6s crosser cto recanalization catheter was returned for evaluation.It was noted the distal tip was detached from the catheter and was not returned with sample.The distal marker band was not attached, outer catheter is also noted to be stretched.Distal tip detachment measures 105.5 cm from break to strain relief.Based on the findings, the investigation is confirmed for the reported detachment issue as the it was noted hat the distal tip was completely detached form the catheter.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiration date: 10/2022),g3, h6(method).H11: b5, h1, h6(patient, result and conclusion).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 : see h10.

Event Description

It was reported that during a recanalization procedure, the tip of the catheter allegedly detached.It was further reported that the tip was left in the calcified lesion.The current status of the patient was unknown.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11839990
• MDR Text Key: 251187612
• Report Number: 2020394-2021-01055
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125642
• UDI-Public: (01)10801741125642
• Combination Product (y/n): N
• PMA/PMN Number: K161208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRUS6106
• Device Catalogue Number: CRUS6106
• Device Lot Number: GFEY2153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR