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

Model Number	CRUO14SA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 11/2021).
Event or Problem Description
It was reported that during preparation of the recanalization procedure, the distal tip of the device allegedly separated from the catheter while being inserted into the sheath.There were no patient contact.
Event or Problem Description
It was reported that during preparation of the recanalization procedure, the distal tip of the device allegedly separated from the catheter while being inserted into the sheath.There were no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 14s crosser cto recanalization catheter was returned for evaluation.Sample was noted to have residue at the distal end of the outer lumen.No kinks noted to the catheter, no anomalies noted to transducer handle, or saline hub.Marker band is present and undamaged.Material separation was noted approximately 3mm from below the distal tip.Based on the findings, the reported material separation issue can be confirmed as a tip separation noted to the device.Additionally, one electronic photo was provided and reviewed.The photo shows the distal tip of the crosser catheter.The tip separation from the catheter can be noted to the device.Therefore, based on the photo review, the reported material separation issue can be confirmed as a tip separation noted to the device.A definitive root cause for the reported material separation issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 11/2021), g3, h6 (method).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 CATHETER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12022848
• Report Number: 2020394-2021-01223
• Device Sequence Number: 16488010
• Product Code: PDU
• UDI-Device Identifier: 10801741125598
• UDI-Public: (01)10801741125598
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: Health Professional
• Device Model Number: CRUO14SA
• Device Catalogue Number: CRUO14SA
• Device Lot Number: GFDY0836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other