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

Model Number	39575
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that device contamination was encountered.A 035/260/1 amplatz super stiff guidewire was selected for use.However, before the device was opened, it was noted, that the tip of the hoop got stuck into the adhesive part of the packaging bag and it had a hole.Consequently, the sterility of the device was not maintained.It was noted, that the device was placed in the outer box during delivery and was stored on the shelf of the catheterization room.The procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that device contamination was encountered.A 035/260/1 amplatz super stiff guidewire was selected for use.However, before the device was opened, it was noted that the tip of the hoop got stuck into the adhesive part of the packaging bag and it had a hole.Consequently, the sterility of the device was not maintained.It was noted that the device was placed in the outer box during delivery and was stored on the shelf of the catheterization room.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).Device evaluated by mfr: unit returned with its original unopened pouch.The device returned inside the original pouch; it was observed that the seal of the pouch was damaged, and it is possible to observe a hole on one side, and it was observed that the pouch information matches with the complaint information.A pouch is received with a damaged seal from the supplier, upon reviewing this it presents the characteristic seal mark, confirming that it was sealed.No more damages were observed.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16781281
• Report Number: 2124215-2023-16530
• Device Sequence Number: 12446396
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: 08714729295655
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843012
• 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): 06/12/2023

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: 12/20/2024
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0028596108
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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