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

Model Number	35615
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was present inside the packaging.An accustick was selected for use in a nephrostomy procedure.Upon unpacking the device, an eyelash was found inside the sterile packaging.The physician opened another device to complete the procedure.The patient experienced no harm as the compromised device was not used.
Additional Manufacturer Narrative
Device analysis by mfr: the returned device consisted of an accustick.Only the unused guidewires were returned for analysis, both guidewires returned in its sealed pouch.The heat seal runs throughout the entire length of the pouch without any damage.One hair was observed inside the pouch.
Event or Problem Description
It was reported that foreign matter was present inside the packaging.An accustick was selected for use in a nephrostomy procedure.Upon unpacking the device, an eyelash was found inside the sterile packaging.The physician opened another device to complete the procedure.The patient experienced no harm as the compromised device was not used.

• 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: 9199126
• Report Number: 2134265-2019-12514
• Device Sequence Number: 448943
• Product Code: KGZ
• UDI-Device Identifier: 08714729201137
• UDI-Public: 08714729201137
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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 Model Number: 35615
• Device Catalogue Number: 35615
• Device Lot Number: 0024193412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1