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

Model Number	35615
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip was torn.The target lesion area was located in the liver.An accustick ii was selected for use.During preparation, it was noted that the tip was torn.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Unit returned with its original pouch batch 23871328, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.Visual inspection performed.One accustick device was returned for analysis (dilator, sheath and molded stiffener).Residues observed on the dilator and sheath indicate use and handling of the device.No visual issues were observed with the dilator and molded stiffener.The tip of the sheath was not torn, however it was damaged (bent outwards).
Event or Problem Description
It was reported that the tip was torn.The target lesion area was located in the liver.An accustick ii was selected for use.During preparation, it was noted that the tip was torn.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• 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: 9595795
• Report Number: 2134265-2020-00125
• Device Sequence Number: 14353541
• Product Code: KGZ
• UDI-Device Identifier: 08714729157625
• UDI-Public: 08714729157625
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• 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): 03/02/2020

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: 05/28/2022
• Device Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0023871328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1