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

Model Number	M00545820
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf impact code (b)(4) is being used to capture the reportable event of rescheduled procedure.
Event or Problem Description
Note: this report pertains to one rapid exchange, three tandem xl, and two contour ercp cannula used in the same procedure.It was reported to boston scientific corporation that a rapid exchange was used in the "small bowel" during a duodenal stent procedure.The exact procedure date was unknown.During the procedure, there was difficulty advancing the rapid exchange over the guidewire.Similar problem happened when another three tandem xl and two contour ercp cannula were used.It was reported that the devices were "seemed to be incompatible." the patient was rescheduled for another procedure to have the stent placed.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 16390799
• Report Number: 3005099803-2023-00757
• Device Sequence Number: 5605651
• Product Code: GCJ
• UDI-Device Identifier: 08714729301905
• UDI-Public: 08714729301905
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/16/2023

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 Model Number: M00545820
• Device Catalogue Number: 4582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown