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

Catalog Number CRE14S

Device Problems Overheating of Device (1437); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2014

Event Type  malfunction  

Event Description

It was reported that following 40-45 seconds of activation time, the recanalization catheter felt warm ot the touch.The catheter was retracted without incident.Another catheter was used to successfully complete the procedure.

Manufacturer Narrative

The device history records have been reviewed with special attention to the raw materials, subassemblies, mfg process, and qc testing.This lot met all release criteria.There was nothing found to indicate there was a mfg related cause for this event.The device was returned for eval and the distal tip and distal metal marker band were not present on the catheter.The outer catheter was perforated 0.6cm from the distal tip, likely due to the core wire break.The core wire remaining within the catheter was measured to be 140.9cm, indicating that the tip detached at the tip weld.Therefore, 5.1cm of the core wire broke off with the distal tip and was not returned with the sample.This indicate that the core wire broke along the length of the wire and not at the tip weld.The break appeared clean as no rough surfaces were identified.The detached distal tip will be considered an incidental finding, as the user reported that the tip detached outside the pt after trying to remove the guidewire from the catheter.The investigation is inconclusive for overheating of the device and inconclusive for difficulty removing the guidewire from the distal tip.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.This file was missing patient details.Email sent to international representative regarding patient information missing from the file.Multiple follow up attempts were made with the international representative to obtain any information pertaining to the patient details that were not previously obtained during the initial investigation.The international representative was unable to provide any details.The information provided by bard 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 bard.

Event Description

It was reported that following 40-45 seconds of activation time, the recanalization catheter shaft overheated.The catheter was retracted without incident.Another catheter was used to successfully complete the procedure.Reportedly after the procedure, it was identified that the guidewire was torn and stuck in the catheter.After multiple attempts were made to remove both devices, the distal tip of the catheter detached with the guidewire.There was no reported patient injury.

• Brand Name: CROSSER RECANALIZATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804 2045
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4811472
• MDR Text Key: 19635120
• Report Number: 2020394-2015-00593
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: CRE14S
• Device Lot Number: GFXL0249
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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