MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZEBRA; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066701091
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a zebra guidewire was used during holmium laser lithotripsy procedure on (b)(6) 2022.During preparation, one guidewire in a box of five was not sealed and had an opening.The sterile barrier was compromised however there was no visible damage noted on the outer packaging.The procedure was not completed due to this event and device was out of stock.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter state:(b)(6).(b)(4).
Event or Problem Description
T was reported to boston scientific corporation that a zebra guidewire was used during holmium laser lithotripsy procedure on (b)(6) 2022.During preparation, one guidewire in a box of five was not sealed and had an opening.The sterile barrier was compromised however there was no visible damage noted on the outer packaging.The procedure was not completed due to this event and device was out of stock.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter state): (b)(6).Block h6 (device): device code a020503 captures the reportable event of unsealed device packaging.Block h10: a zebra guidewire was returned.The pouch returned open with evidence that it was manipulated, it was found that pouch head seal rubber residues for both, the chevron part (supplier seal) and the tyvek seal part (bsc seal).In addition, in the analysis, rubber residues of a label were found in the front section, and the pouch came closed with a staple.Therefore, the reported event was not confirmed.Based on a review of all available information, the cause of the reported event could not be determined.The product record review results and external support form meets all manufacturing specifications required and passed all the controls and inspections; no abnormalities were reported during the assembly process.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, cause not established is selected as the most probable cause for the complaint.

• Brand Name: ZEBRA
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15380261
• Report Number: 3005099803-2022-05109
• Device Sequence Number: 5661559
• Product Code: EZB
• UDI-Device Identifier: 08714729191223
• UDI-Public: 08714729191223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: 03/28/2024
• Device Model Number: M0066701091
• Device Catalogue Number: 670-109
• Device Lot Number: 0027057033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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 Age: 13 YR
• Patient Sex: Male
• Patient Weight: 45 KG