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

Catalog Number CRE14S

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The product classification code for the crosser cto recanalization catheters product is identified.The lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

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

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the crosser cto recanalization catheters products that are cleared in the us.The product classification code for the crosser cto recanalization catheters product is identified in d2.H10: the lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation is confirmed for detachment of device.A definitive root cause for the reported event could not be determined.The device is labeled for single use.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.

Event Description

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

• 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: 9963688
• MDR Text Key: 189197414
• Report Number: 2020394-2020-02713
• 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: 10/21/2020

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: GFDU0364
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1