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

Model Number	39575
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of aware date as no information was provided.
Event or Problem Description
It was reported that device contamination occurred.A 035/260 (bx/1) amplatz super stiff guidewire was selected for use; however, a hairlike substance was noted within the sterilization bag before the device was opened.No patient injuries were reported.
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of aware date as no information was provided.Device evaluated by mfr.: unit returned with its original unopened pouch.The device was inspected according to procedure.The customer attached pictures of the device, and it was observed a hair through the pouch near of the device.The unit return inside its original unopened pouch, and a hair was observed through the pouch.Also, it was observed that the pouch information matches with the complaint information.The foreign material observed was measured and the result was out of specification.The dimensions measured were inspected against the document.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that device contamination occurred.A 035/260 (bx/1) amplatz super stiff guidewire was selected for use; however, a hairlike substance was noted within the sterilization bag before the device was opened.No patient injuries were reported.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15941111
• Report Number: 2124215-2022-49579
• Device Sequence Number: 6059513
• Product Code: DQX
• UDI-Device Identifier: 08714729295747
• UDI-Public: 08714729295747
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 09/28/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0030251220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown