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

Catalog Number CRUO14SA

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.( expiration date: 10/2019).

Event Description

It was reported during cto treatment in the sfa via antegrade access, the tip of the recanalization catheter was allegedly detached.It was further reported that the tip was retrieved and a catheter was used to pass the lesion.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.Investigation summary: one crosser 14s catheter was returned for evaluation.The crosser catheter was returned inserted inside a sidekick catheter.The device was placed in x-ray and no breaks in the corewire or distal tip were identified.The tip of the sidekick is buckled indicating retraction issues.Therefore, the investigation is confirmed for retraction issue.The investigation is unconfirmed for tip detachment as the device was returned with the distal tip attached with no identified breaks.Per the evaluation results, the catheter was in specification, so it is unlikely that the shaft diameter was too large for the outer catheter.Based upon the available information, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported during cto treatment in the sfa via antegrade access, the tip of the recanalization catheter was allegedly detached.It was further reported that the tip was retrieved and a catheter was used to pass the lesion.There was no reported patient injury.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Type of Device: RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8129508
• MDR Text Key: 129216397
• Report Number: 2020394-2018-02157
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 10801741125598
• UDI-Public: (01)10801741125598
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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: CRUO14SA
• Device Lot Number: GFBY0762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 88