MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2779
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was not provided at the time of reporting.The first date of the month of the aware date was selected.Initial reporter facility name (b)(6).Initial reporter address (b)(6).
Event or Problem Description
It was reported that product package was compromised.A pt2 light support 185cm straight, 1-pack guidewire was unpacked.However, it was noted that the seal was broken.The device never entered into the patient's body.
Event or Problem Description
It was reported that product package was compromised.A pt2 light support 185cm straight, 1-pack guidewire was unpacked.However, it was noted that the seal was broken.The device never entered into the patient's body.
Additional Manufacturer Narrative
B3: date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.(b)(6).Device evaluated by mfr.: a pt2 light support was returned with its original unopened pouch, no damages were observed.The returned device matches with upn and lot provided by the customer.The original cardboard box was not returned.Customer attached a picture showing the original box of the device with the seal tab opened.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12204359
• Report Number: 2134265-2021-09343
• Device Sequence Number: 4227301
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: 08714729471103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 11/25/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0026424922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1