MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE THREADER¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927012120

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was not returned for analysis.The investigation conclusion is design: product enhancement as the device met the designed specification however a modification would improve performance, function or appearance of the product.(b)(4).

Event Description

It was reported that the protective sheath was almost left on during the procedure.The target lesion was located in the left anterior descending artery.A 1.2mm x 12mm threader¿ dilatation catheter was selected for a chronic total occlusion (cto) procedure.The device was advanced in the patient.The plastic piece that comes with the stylet and covers the balloon is tough to see on the catheter; and was noted that it was still on the device.The device was removed and the plastic piece was taken off.The procedure was still completed with this device.No patient complications were reported and the patient's status was fine.

• Brand Name: THREADER¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 7323640
• MDR Text Key: 101980916
• Report Number: 2134265-2018-01473
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K134031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493927012120
• Device Catalogue Number: 39270-1212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• 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