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

Catalog Number CRE14S

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in device information 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 common device name and pma/510k.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.The investigation of the reported event is currently underway.Expiry date: 08/2024.

Event Description

It was reported that during a recanalization procedure, the tip of the catheter allegedly separated.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a recanalization procedure, the tip of the catheter allegedly detached after one twenty seconds of activation.The procedure was completed using another device.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 catheters products that are cleared in the us.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 and a packaging hoop was returned for evaluation.Visual evaluation revealed that the distal tip was detached from the inner corewire and not returned.A slight tear was observed to the distal end of the catheter.The marker band is present and undamaged.No functional testing was performed due to the nature of the complaint.Based on the findings, the investigation is confirmed for the reported tip detachment issue.The investigation is also confirmed for the identified material tear issue as the catheter was teared.A definitive root cause for the reported tip detachment and the identified material tear 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: b5, d4 (expiry date: 08/2024).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.

Event Description

It was reported that during a recanalization procedure, the tip of the catheter allegedly detached after 120 seconds of activation.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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.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 and a packaging hoop was returned for evaluation.Visual evaluation revealed that the distal tip was detached from the inner corewire and not returned.A slight tear was observed to the distal end of the catheter.The marker band is present and undamaged.No functional testing was performed due to the nature of the complaint.Based on the findings, the investigation is confirmed for the reported tip detachment issue.The investigation is also confirmed for the identified material tear issue as the catheter was teared.A definitive root cause for the reported tip detachment and the identified material tear 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.D4 (expiry date: 08/2024).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: 15830828
• MDR Text Key: 307664763
• Report Number: 2020394-2022-00907
• 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,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• 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: GFGU0379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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