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

Model Number	CRUS6A
Medical Device Problem Codes	Break (1069); Reflux within Device (1522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for the one complaint.The company is still investigating the issue at this time.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 crus6a.Recanalization catheter allegedly broke.It was further reported that another device was used to complete the procedure.This information was received from single source.This event did involve patient with no reported patient injury.The patient is (b)(6) years of age, the gender is not provided, and the weight is (b)(6) lbs.
Additional Manufacturer Narrative
H10: the device was returned to bd for evaluation.The company is still investigating the issue at this time.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 crus6a.Recanalization catheter allegedly broke.This information was received from single source.This malfunction did involve patient with no reported patient injury.The patient is 74 years of age, the gender is not provided, and the weight is 250 lbs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model crus6a recanalization catheter allegedly broke.This information was received from single source.This malfunction did involve patient with no reported patient injury.The patient is 74 years of age, the gender is not provided, and the weight is 250 lbs.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned to bd for evaluation and the investigation is inconclusive for break, however, confirmed for reflux in device.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.

• 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: 8782986
• Report Number: 2020394-2019-01465
• Device Sequence Number: 11235263
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• 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,Followup
• Report Date (Section B): 01/20/2020

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: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFDQ2952
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 10/10/2019; 01/20/2020
• Patient Sequence Number: 1