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

Model Number	CRUS6106
Medical Device Problem Codes	Break (1069); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
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.The investigation of the reported event is currently underway.Expiry date (12/2021).
Event or Problem Description
It was reported that during an angioplasty procedure, the catheter was allegedly broke and the device was making a weird noise.It was further reported that the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history report was conducted and the results showed that this is the only complaint for this lot number to date.Therefore, a device history record review is not required.Investigation summary: one crosser s6 cto recanalization catheter was returned for review.Visual evaluation of the crosser revealed a catheter detachment at the distal end of the device.Therefore, the investigation is confirmed for detachment of device or device component.No functional testing was performed due to the condition of the sample, therefore, the investigation is inconclusive for noise audible.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: d4 (expiry date: 12/2021).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 : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure, the catheter was allegedly broke and the device was making a weird noise.It was further reported that the procedure was completed using another device.There was no reported patient injury.

• 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: 10710054
• Report Number: 2020394-2020-20188
• Device Sequence Number: 3281185
• Product Code: PDU
• UDI-Device Identifier: 10801741125642
• UDI-Public: (01)10801741125642
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/16/2021

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: CRUS6106
• Device Catalogue Number: CRUS6106
• Device Lot Number: GFDY3036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 04/27/2021
• 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