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

Model Number	35615
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8795069
• Report Number: 2134265-2019-08091
• Device Sequence Number: 13947426
• Product Code: KGZ
• UDI-Device Identifier: 08714729157601
• UDI-Public: 08714729157601
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K952828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other