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

Model Number	CRUO14SA
Medical Device Problem Codes	Material Separation (1562); Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore the investigation is confirmed for material separation, material deformation and inconclusive for device-device incompatibility.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruo14sa recanalization catheter allegedly experienced device-device incompatibility, material separation and material deformation.This report was received from one source.This malfunction involved one patient with no patient consequences.The (b)(6) year old female patient was (b)(6) lbs.
Additional Manufacturer Narrative
H10: the lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore the investigation is confirmed for material separation, material twist and inconclusive for device-device incompatibility.Based upon the available information, the definitive root cause for this event 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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model cruo14sa recanalization catheter allegedly experienced device-device incompatibility, material separation and material twist.This report was received from one source.This malfunction involved one patient with no patient consequences.The 72 year old female patient was 120 lbs.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10268722
• Report Number: 2020394-2020-04398
• Device Sequence Number: 2310100
• Product Code: PDU
• UDI-Device Identifier: 10801741125598
• UDI-Public: (01)10801741125598
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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
• Operator of Device: No Information
• Device Model Number: CRUO14SA
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFDZ2385
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1