MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER

Model Number 35615

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that guidewire tip broke off and remains in the patient.An accustick ii was selected for a percutaneous transhepatic cholangiodrainage (ptcd) procedure.A successful puncture of the bile duct was made.The guidewire was inserted without complications into the bile ducts.While attempting to insert the dilator, the 0.018 in (0.47 mm) stainless steel guidewire with a 7.5 cm floppy tip broke off, without greater force, at the level of the ribs.A piece of the wire, approximately 10 cm long, remains in the liver.An attempt was made to retrieve the wire using forceps, but this was unsuccessful.The patient did not experience any complications or symptoms as a result.The procedure was completed with a new accustick.

Manufacturer Narrative

Date of birth: year (b)(6).Device evaluated by mfr: one accustick system was returned for analysis.Residues were observed on the device indicating use and handling.No issues were observed with the accustick introducer.The guidewire was received broken and the broken section was not returned for analysis.The distal section of the returned guidewire was kinked approximately 1cm from the breakage area.The broken area of the wire showed evidence of bending.The section of the guidewire received measured 48.2cm.Per specification, it should measure 60.0cm plus/minus 1.0cm, indicating approximately 12cm of the wire was not returned.

Event Description

It was reported that guidewire tip broke off and remains in the patient.An accustick ii was selected for a percutaneous transhepatic cholangiodrainage (ptcd) procedure.A successful puncture of the bile duct was made.The guidewire was inserted without complications into the bile ducts.While attempting to insert the dilator, the 0.018in (0.47 mm) stainless steel guidewire with a 7.5 cm floppy tip broke off, without greater force, at the level of the ribs.A piece of the wire, approximately 10 cm long, remains in the liver.An attempt was made to retrieve the wire using forceps, but this was unsuccessful.The patient did not experience any complications or symptoms as a result.The procedure was completed with a new accustick.

• Brand Name: ACCUSTICK II
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8795069
• MDR Text Key: 151188254
• Report Number: 2134265-2019-08091
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 08714729157601
• UDI-Public: 08714729157601
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K952828
• 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,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0023211328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other