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

Catalog Number CRE14S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/26/2023

Event Type  Injury  

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 and 510 k number for the crosser cto recanalization catheters products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 05/2025).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.

Event Description

It was reported that during a recanalization procedure of a highly calcified target lesion in the superficial femoral artery, tip of the catheter was allegedly detached after three minutes of activation.It was further reported that the guidewire was also retraced upon removing the device, so the detached segment was allegedly unable to be found and left inside the patient.Reportedly, the procedure was completed by using a stent to crimp to the blood vessel wall.The current status of the patient is unknown.

• Brand Name: CROSSER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17963066
• MDR Text Key: 326005022
• Report Number: 2020394-2023-00900
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125420
• UDI-Public: (01)10801741125420
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRE14S
• Device Lot Number: GFHR0708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention