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

Model Number	35615
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a crack at the tip of the dilator.The 90% stenosed target lesion was located in the moderately tortuous common bile duct.An accustick ii kit was selected for use to insert a drainage catheter.During the procedure, when the physician withdrew the dilator from the patient's body, he found that there was a crack at the tip of the dilator.There was a small pinhole and linear cracking found.No visible separation nor debris was found.The dilator was completely removed from the patient's body through the guidewire in accustick set and the puncture was completed using this device.No patient complications were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that there was a crack at the tip of the dilator.The 90% stenosed target lesion was located in the moderately tortuous common bile duct.An accustick ii kit was selected for use to insert a drainage catheter.During the procedure, when the physician withdrew the dilator from the patient's body, he found that there was a crack at the tip of the dilator.There was a small pinhole and linear cracking found.No visible separation nor debris was found.The dilator was completely removed from the patient's body through the guidewire in accustick set and the puncture was completed using this device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: one accustick device was returned for analysis (stiffening cannula, dilator and sheath).The devices did not have any broken section.The distal section of the cannula, dilator and sheath had a severe kink.The tip of the dilator was damaged.Functional inspection was performed and the components could not be taken apart due to severe kinking at distal section.No other issues were identified during the product analysis.

• 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: 10836891
• Report Number: 2134265-2020-15789
• Device Sequence Number: 4090058
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: 08714729201137
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 09/03/2023
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0025963124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR