MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE DIREXION; CATHETER, CONTINUOUS FLUSH

Model Number M001195220

Device Problems Peeled/Delaminated (1454); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the hydrophilic coating peeled off from the catheter.A direxion microcatheter was selected for use.During unpacking, it was noticed that the hydrophilic coating was coming away from the catheter.The procedure was then completed with another of the same device.There were no patient complications reported.The patient's status was stable.

• Brand Name: DIREXION
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6941646
• MDR Text Key: 90078835
• Report Number: 2134265-2017-10121
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K132947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001195220
• Device Catalogue Number: 19-522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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