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

Catalog Number CRE14S

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review 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.The catalog number identified 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.(expiry date: 09/2022).

Event Description

It was reported that during a recanalization procedure of calcified lesion in the superficial femoral artery via ipsilateral antegrade approach, the tip of the catheter allegedly detached within one minute of activation.It was further reported that the tip was removed with the catheter and another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a recanalization procedure of calcified lesion in the superficial femoral artery via ipsilateral antegrade approach, the tip of the catheter allegedly separated within one minute of activation.It was further reported that the tip was removed with the catheter and another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged material separation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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: d4 (expiry date: 09/2022), g3 h11: b5, h6 (device) 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.Device not returned.

• Brand Name: CROSSER CTO RECANALIZATION CATHETERS
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11122060
• MDR Text Key: 225254519
• Report Number: 2020394-2020-21027
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• PMA/PMN Number: K161208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: CRE14S
• Device Lot Number: GFEV1296
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other