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

Model Number	7214
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in left anterior descending artery.A 3.75mm x 20mm nc emerge balloon catheter was advanced for dilatation.After balloon inflation, the physician attempted to remove the device.However, the device was stuck on the unknown guidewire.Both the balloon catheter and the wire were pulled as a unit.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in left anterior descending artery.A 3.75mm x 20mm nc emerge balloon catheter was advanced for dilatation.After balloon inflation, the physician attempted to remove the device.However, the device was stuck on the unknown guidewire.Both the balloon catheter and the wire were pulled as a unit.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast present in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The guidewire lumen was buckled and prolapsed 46mm from the tip at 5mm in length.Product analysis confirmed the reported event as the guidewire lumen was buckled and prolapsed.The damage is likely consistent with an interaction with a guidewire and could cause difficulty advancing and the wire to freeze up within the device during use or removal.

• Brand Name: NC 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: 14958108
• Report Number: 2134265-2022-07093
• Device Sequence Number: 5395865
• Product Code: LOX
• UDI-Device Identifier: 08714729846680
• UDI-Public: 08714729846680
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 02/21/2024
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0028911662
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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: 49 YR
• Patient Sex: Male