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

Catalog Number CRE14S

Device Problems Material Frayed (1262); Retraction Problem (1536); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the crosser cto recanalization catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).

Event Description

It was reported that during a recanalization procedure in the anterior tibial artery below the knee via an ipsilateral approach, the catheter was allegedly detached.Reportedly, the catheter was allegedly got stuck upon retracing and the tip of the catheter was completely separated from the catheter.It was further reported that the distal catheter segment was removed.There was no reported patient injury.

Event Description

It was reported that during a recanalization procedure in the anterior tibial artery below the knee via an ipsilateral approach, the catheter was allegedly detached.Reportedly, the catheter was allegedly got stuck upon retracing and the tip of the catheter was completely separated from the catheter.It was further reported that the distal catheter segment was removed.There was no reported patient 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 catheter products that are cleared in the us.The pro code and 510 k number for the crosser cto recanalization catheter products are identified in d2 and g4.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: one 14s crosser cto recanalization catheter was returned for evaluation.During visual evaluation, the distal tip is detached and not returned.The marker band is noted to be deformed.The catheter was noted to be frayed near to the marker band.No functional testing performed due to the condition of the device.Based on the findings, the investigation is confirmed for the detachment issue as the distal tip was noted be detached and not returned.The investigation is also confirmed for the material fray and material deformation issue as the catheter was noted to frayed and marker band was deformed.However, the investigation is inconclusive for the retraction issue, as there is no functional testing due to the condition of the device.A definitive root cause for the reported detachment, retraction issue and the identified material fray, material deformation issues 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: d4 (expiry date: 10/2023), g3, h6 (device, method).H11:section a through f - the information provided by bd represents all of 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
• 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: 15400084
• MDR Text Key: 302726953
• Report Number: 2020394-2022-00731
• 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,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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: GFFW2245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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