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

Model Number	M00545820
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rapid exchange was intended to be used in the gastro biliary tract in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, it was found that the package of the device was opened and not sealed.The complete weld seam at the bottom edge of the package was missing, compromising the sterile barrier.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a rapid exchange was intended to be used in the gastro biliary tract in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2022.During preparation, it was found that the package of the device was opened and not sealed.The complete weld seam at the bottom edge of the package was missing, compromising the sterile barrier.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a020503 captures the reportable event of unsealed device packaging, compromising the sterile barrier.Block h10: the returned rapid exchange was analyzed, and a visual evaluation noted that the package was missing one welding, which matches to the finding through media analysis based on the provided photo.The device did not present any problems.No other problems with the device were noted.The reported event of unsealed device packaging was confirmed.Upon analysis, it was found that the package had one welding missing, leaving the seal incomplete.This condition, incomplete seal packaging, is related to manufacturer deficiency.Therefore, it was concluded based on the information available and the analysis performed to the returned device, the root cause of this complaint is manufacturing deficiency.An investigation to address this issue is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 13995055
• Report Number: 3005099803-2022-01714
• Device Sequence Number: 14605620
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 01/17/2024
• Device Model Number: M00545820
• Device Catalogue Number: 4582
• Device Lot Number: 0028693663
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• 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