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

Catalog Number CRE14S

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 04/16/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified in section has not been cleared in the us but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified.(expiry date: 01/2023).

Event Description

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

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified in d2 and g4.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 14s 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 attached.Distal tip detachment measures 145.5 cm from break to strain relief.Based on the findings, the investigation is confirmed for the reported tip detachment issue as it was noted that the distal tip was detached from the catheter.A definitive root cause for the reported detachment issue could not be determined based upon the provided information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 01/2023 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 Description

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

• Brand Name: CROSSER CTO RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11824299
• MDR Text Key: 250581861
• Report Number: 2020394-2021-01045
• Device Sequence Number: 1
• Product Code: PDU
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRE14S
• Device Lot Number: GFEZ2551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR