MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7130
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: fg emerge mr, us 1.20mm x 8mm was received for analysis.A visual, tactile, microscopic analysis and wire insertion test was performed on the device.A visual, tactile examination identified no issues with the hypotube shaft.A microscopic examination of the inner/wire lumen noted that the lumen was bunched at 6.8cm proximal from the tip.A puncture hole was identified in the outer extrusion at 7cm from the tip.As a result of the damage to the inner wire lumen, it was not possible to load a recommended 0.014inch wire through the guidewire lumen.A microscopic examination of the balloon identified no issues with the balloon.Examination of the tip via the scope found no evidence of any damage.
Event or Problem Description
Reportable based on device analysis completed on 30aug2024.It was reported that crossing difficulties were encountered.The patient was undergoing percutaneous coronary intervention.The 90% stenosed target lesion was located in the left circumflex artery.A 1.20mm x 8mm emerge balloon catheter was selected for use.During the procedure, a non-boston scientific guidewire could not cross the balloon.The procedure was completed with another of same device.No patient complications were reported, and the patient was stable post-procedure.However, returned device analysis revealed that shaft polymer extrusion ruptured.
Additional Manufacturer Narrative
A corrective action was opened to further investigate the issue of difficulty loading the wire and difficulty tracking over the wire.The investigation is in process, and no actions have been taken at the time of this regulatory report submission.H6: updated the evaluation conclusion code from unintended use error caused or contributed to event to cause not established e1: initial reporter city: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: fg emerge mr, us 1.20mm x 8mm was received for analysis.A visual, tactile, microscopic analysis and wire insertion test was performed on the device.A visual, tactile examination identified no issues with the hypotube shaft.A microscopic examination of the inner/wire lumen noted that the lumen was bunched at 6.8cm proximal from the tip.A puncture hole was identified in the outer extrusion at 7cm from the tip.As a result of the damage to the inner wire lumen, it was not possible to load a recommended 0.014inch wire through the guidewire lumen.A microscopic examination of the balloon identified no issues with the balloon.Examination of the tip via the scope found no evidence of any damage.
Event or Problem Description
Reportable based on device analysis completed on 30aug2024.It was reported that crossing difficulties were encountered.The patient was undergoing percutaneous coronary intervention.The 90% stenosed target lesion was located in the left circumflex artery.A 1.20mm x 8mm emerge balloon catheter was selected for use.During the procedure, a non-boston scientific guidewire could not cross the balloon.The procedure was completed with another of same device.No patient complications were reported, and the patient was stable post-procedure.However, returned device analysis revealed that shaft polymer extrusion ruptured.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20305884
• Report Number: 2124215-2024-57463
• Device Sequence Number: 18314430
• Product Code: LOX
• UDI-Device Identifier: 08714729806486
• UDI-Public: 08714729806486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• 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): 03/11/2025

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: 08/09/2026
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0033012934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 55 KG