MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RAPID EXCHANGE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M00545820
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	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a rapid exchange was intended to be used in a procedure performed on (b)(6) 2022.During preparation outside the patient, as the package was attempted to be opened, "a black garbage-like substance" was noticed inside the packaging; hence, the package was not opened.It was reported that there was no damage on the device pouch or seal.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign material present in the packaging of the device.Block h10: the returned rapid exchange was analyzed, and a visual evaluation noted that there was no evidence of the problem found.No problems with the device were noted.The reported event of a black garbage-like substance observed in the bag was not confirmed.Upon analysis, the device was free of foreign matter inside the pouch.The returned unit did not show evidence of either the alleged problem or any defect that could have contributed to the event reported.Based on all gathered information, the overall conclusion for the complaint will be no problem detected.Block h2 (additional information): block b5 has been updated based on the additional information received on february 27, 2023.
Event or Problem Description
It was reported to boston scientific corporation that a rapid exchange was intended to be used in a procedure performed on (b)(6) 2022.During preparation outside the patient, as the package was attempted to be opened, "a black garbage-like substance" was noticed inside the packaging; hence, the package was not opened.It was reported that there was no damage on the device pouch or seal.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Additional information received on (b)(6) 2023: it was reported that a "foreign substance" in the actual product was noticed; however, it was not checked if it was located in the device packaging or if it was in the outer pouch.

• Brand Name: RAPID EXCHANGE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 16198607
• Report Number: 3005099803-2023-00108
• Device Sequence Number: 14954161
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970054
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 09/01/2024
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 0030079691
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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