MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STARTER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number M001492231

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

Same case as mdr 2134265-2014-00136.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: examination of the complaint device revealed dried blood like material between the coil wraps and adjacent to the weld regions, scraped/abraded ptfe coating over the proximal 2 ¿ 3cm, very large radius serpentine bends over the length of the device proximal of the j-formed tip.The -fs function is impaired; likely due to the deposits of dried blood-like material between the coil wraps and within the coil lumen.No other damage or inconsistencies are noted to the specimen at this time.All joints appear to be correct and intact by visual examination and by non-destructive testing.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 2134265-2014-00136.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: STARTER GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): LAKE REGION MANUFACTURING; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3566535
• MDR Text Key: 20326488
• Report Number: 2134265-2013-09539
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K935170
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: M001492231
• Device Catalogue Number: 49-223
• Device Lot Number: 0010267833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 01/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2013
• 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