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

Model Number	7214
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a nc emerge mr balloon catheter.The balloon was tightly folded, and there was blood in the wire lumen (shaft).Analysis of the tip, inner/outer shaft, port weld/exit notch and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, the device tip was missing/separated with the area damaged, and inner shaft damage (stretched and buckling).Inspection of the rest of the device found no other damage or defects.The wire used in the procedure was not returned for analysis, so a test wire was used for device to device testing.The wire could not be loaded into the distal tip area due to the damaged/separated material.The wire was then loaded into the port weld/exit notch and was able to be advanced in the wire lumen/shaft for a length of 20 cm and then stopped.The wire stopped advancing at the observed area of shaft stretching/buckling.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that difficulty to load wire and obstruction within device were encountered.The 70% stenosed target lesion was located in a calcified vessel.A 3.50mm x 20mm nc emerge balloon catheter was selected for use but there seemed to be something blocking the lumen on the tip of the balloon and was unable to put the balloon onto the wire at all.The device was never entered into the patient's body.However, device analysis revealed a tip detachment/separated.

• 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
• MDR Report Key: 11334436
• Report Number: 2134265-2021-01357
• Device Sequence Number: 823284
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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: 09/22/2022
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0026056008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1