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

Model Number	CRUS6A
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Failure to Advance (2524); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2024).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 pending return.
Event or Problem Description
It was reported that during a recanalization procedure in the left superficial artery via right groin access, the catheter allegedly became stuck in the lesion.It was further reported that the catheter was allegedly completely broken and stuck inside the support catheter.Furthermore, the catheter allegedly had difficulty in removing from the patient.Reportedly, the physician was able to remove the device from the patient without ripping the vessel apart.There was no reported patient injury.
Event or Problem Description
It was reported that during a recanalization procedure in the left superficial artery via right groin access, the catheter allegedly became stuck in the lesion.It was further reported that the catheter was allegedly completely broken and stuck inside the support catheter.Furthermore, the catheter allegedly had difficulty in removing from the patient.Reportedly, the physician was able to remove the device from the patient without ripping the vessel apart.The crosser is still stuck inside the support catheter.There was no reported patient injury.
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 6s crosser cto recanalization catheter loaded on to usher support catheter was received for evaluation.Upon visual evaluation, bunching and twisting was noted to the distal end of the catheter.During function testing, an attempt was made to remove the crosser from support catheter however was unsuccessful.No further functional testing performed.Therefore, the investigation is inconclusive for the reported failure to advance, since the condition of use could not be replicated in the laboratory condition and the investigation is inconclusive for the reported break since the entire catheter was not visible and still stuck inside the support catheter.The investigation is confirmed for the reported retraction issue as crosser was not able to be removed from support catheter during functional testing.The investigation is confirmed for the reported device device incompatibility as crosser was returned stuck inside the support catheter.The investigation is confirmed for the identified material twist issue as twisting was noted to the distal end of the catheter.A definitive root cause for the reported failure to advance, retraction problem, break, device device incompatibility and identified material twist 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: b5, d4 (expiration date: 08/2024), g3, h6 (device).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.

• Brand Name: CROSSER
• Common Device Name: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 17018301
• Report Number: 2020394-2023-00375
• Device Sequence Number: 6286345
• Product Code: PDU
• UDI-Device Identifier: 10801741125659
• UDI-Public: (01)10801741125659
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K161208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: CRUS6A
• Device Catalogue Number: CRUS6A
• Device Lot Number: GFGV0659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female