MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II WITH 038 J-TIP WIRE; ACCESSORIES, CATHETER

Model Number	GTIN 08714729157588
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During nephrostomy tube placement, a 6 fr introducer dilator system was advanced over the 0.018 wire; the wire was exchanged for a larger j wire.When radiologist tried to remove the introducer, the metalic tip of the introducer separated from the introducer and was in the perinephric space.Numerous attempts to remove the avulsed dilated tear was unsuccessful.

• Brand Name: ACCUSTICK II WITH 038 J-TIP WIRE
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 6787565
• Report Number: MW5071508
• Device Sequence Number: 1852597
• Product Code: KGZ
• UDI-Device Identifier: 08714729157588
• UDI-Public: (01)08714729157588(17)200131(10)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: GTIN 08714729157588
• Device Catalogue Number: M001207020
• Device Lot Number: 20113778
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 93