MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39575
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that sterility was compromised.A 035/180 amplatz super stiff guide wire was selected for use.However, it was noted that there was a hair inside the sterile package.The device was never used in a procedure.
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: device returned inside of the original unopened pouch.The pouch has one hair inside of it.The device has a hair inside the pouch.Pouch is completely sealed.
Event or Problem Description
It was reported that sterility was compromised.A 035/180 amplatz super stiff guide wire was selected for use.However, it was noted that there was a hair inside the sterile package.The device was never used in a procedure.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8557543
• Report Number: 2134265-2019-04404
• Device Sequence Number: 16898968
• Product Code: DQX
• UDI-Device Identifier: 08714729295730
• UDI-Public: 08714729295730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K843013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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 Expiration Date: 11/18/2021
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0022961153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1