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

Model Number	CRUS6106
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 07/2023).The information provide 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.
Event or Problem Description
It was reported that during a recanalization procedure, the tip of the catheter allegedly broke off in plaque.Reportedly the tip remains in patient but trapped by stent in iliac.However, no additional intervention or medication required.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows the distal part of the crosser catheter.The distal tip was noted to be missing from the catheter.Therefore, the investigation is confirmed for the detachment issue as the distal tip was noted to be detached in the provided photo.A definitive root cause for the reported tip detachment 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.D4 (expiration date: 07/2023).H11: section a through f: the information provide 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 or Problem Description
It was reported that during a recanalization procedure, the tip of the catheter allegedly broke off in plaque.Reportedly the tip remains in patient but trapped by stent in iliac.There was no reported patient injury.
Event or Problem Description
It was reported that during a recanalization procedure, the tip of the catheter allegedly broke off in plaque.Reportedly the tip remains in patient but trapped by stent in iliac.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 was returned for evaluation.There is no anomaly noted to transducer handle or saline hub.The distal tip and marker band were noted to be missing from the catheter.No functional testing was performed due to the nature of the complaint.Therefore, the investigation is confirmed for detachment of device or device component issue as the distal tip and marker band was noted to be detached and missing from the catheter.One electronic photo was provided and reviewed.The photo shows the distal part of the crosser catheter.The distal tip and marker band was noted to be missing from the catheter.Based on the provided photo, the detachment of device or device component issue can be confirmed.A definitive root cause for the reported tip detachment 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.H11: section a through f: the information provide 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 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: 14460571
• Report Number: 2020394-2022-00392
• Device Sequence Number: 14624221
• Product Code: PDU
• UDI-Device Identifier: 10801741125642
• UDI-Public: (01)10801741125642
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2022

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: CRUS6106
• Device Catalogue Number: CRUS6106
• Device Lot Number: GFFT3129
• 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: 04/30/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 06/21/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/01/2022; 06/24/2022
• 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 Sex: Unknown