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

Catalog Number CRE14S

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The device was returned to bd for evaluation.The investigation identified for material twisted and detachment, but the investigation is still currently underway.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 pro code for the crosser cto recanalization catheters products are identified.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 a activation problem.This information was received from one source.This malfunction involved a patient with no reported patient injury.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 pro code for the crosser cto recanalization catheters products are identified in d2.The lot number was provided and a lot history review was performed.The device was returned to bd for evaluation.The investigation identified for material twisted and detachment, however did not identify an activation problem.Based upon the available information, a definitive root cause is unknown.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 a activation problem.This information was received from one source.This malfunction involved a patient with no reported patient injury.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: 9586872
• MDR Text Key: 180116279
• Report Number: 2020394-2020-00207
• 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: 04/02/2020

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: GFCZ1969
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/02/2020
• Patient Sequence Number: 1