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

Catalog Number CRE14S

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided; therefore, a lot history review is currently being performed.The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.The catalog number identified 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 for the crosser cto recanalization catheter products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced retraction problem and detachment of device or device component.This information was received from one source.One patient was involved with no patient consequences.The age, weight, and gender of the patient was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model cre14s recanalization catheter allegedly experienced retraction problem and detachment of device or device component.This information was received from one source.One patient was involved with no patient consequences.The age, weight, and gender of the patient was not provided.

Manufacturer Narrative

H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation.The sample was not returned for evaluation; therefore, the investigation is inconclusive for the alleged issue.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The device is labeled for single use.H10: g4.H11: g1, h6 (result, conclusion).H10: 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 for the crosser cto recanalization catheter products is identified in d2.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 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: 9968925
• MDR Text Key: 189219983
• Report Number: 2020394-2020-02878
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125420
• UDI-Public: (01)10801741125420
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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: No Information
• Device Catalogue Number: CRE14S
• Device Lot Number: GFDU3094
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/08/2020
• Patient Sequence Number: 1