MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ACCUSTICK? II; INTRODUCER, CATHETER

Model Number M001207040

Device Problems Hole In Material (1293); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

Same case as mdr 2134265-2013-09539.It was reported that the guide wire perforated the introducer sheath.During an insertion of a drainage catheter, the physician advanced a starter guide wire through an accustick ii introducer sheath.However, the guide wire punctured through the wall of the sheath.The devices were successfully removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

(b)(6).(b)(4).

Manufacturer Narrative

Device evaluated by mfr: received one accustick ii w/o.038 with original pouch and product label.Residue observed on device indicates use / handling.The inner sheath only was returned, the stiffener and outer sheath were not returned.The bsc.035 inch guidewire used in the procedure was also returned.The accustick inner sheath was found to have been buckled and have a hole in the sidewall at the same location, 25mm from the distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr 2134265-2013-09539.It was reported that the guide wire perforated the introducer sheath.During an insertion of a drainage catheter, the physician advanced a starter guide wire through an accustick ii introducer sheath.However, the guide wire punctured through the wall of the sheath.The devices were successfully removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

• Brand Name: ACCUSTICK? II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3566534
• MDR Text Key: 4058356
• Report Number: 2134265-2014-00136
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K952828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2016
• Device Model Number: M001207040
• Device Catalogue Number: 20-704
• Device Lot Number: 16479370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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