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

Model Number	7141
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 90% stenosed, 24x3.5mm target lesion was located in the mildly tortuous and moderately calcified right coronary artery (rca).A 2.00mm x 8mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the guidewire could not be pulled out.The balloon was pulled out together with the guidewire intact and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge otw balloon catheter.Photo media was attached in the complaint record.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the guidewire.The balloon was tightly folded.The guidewire used in the procedure was not returned for analysis, so a test 0.014" guidewire was used for functional testing.The guidewire passed through device with no resistance or issues.The guidewire was inserted through the tip of the device and encountered no difficulties.Photo media reviewed, depicts the complaint device with a guidewire, however, no damage is detected to device.Not able to determine if the guidewire shown, is within the complaint device.Product analysis could not confirm the reported event as the test guidewire was able to pass through the device without resistance or issue.There was no damage or irregularity to the returned device.Photo media provided showed both the complaint device and guidewire but depicted no damage and it was not confirmed if the wire was within the device at the time of the photo.
Event or Problem Description
It was reported that device entrapment occurred.The 90% stenosed, 24x3.5mm target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 2.00mm x 8mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the guidewire could not be pulled out.The balloon was pulled out together with the guidewire intact and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15547143
• Report Number: 2124215-2022-37044
• Device Sequence Number: 19322238
• Product Code: LOX
• UDI-Device Identifier: 08714729807117
• UDI-Public: 08714729807117
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 04/18/2024
• Device Model Number: 7141
• Device Catalogue Number: 7141
• Device Lot Number: 0029249703
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 63 KG