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

Model Number	7211
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.At 20.5cm from the strain relief, the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen, and the balloon was tightly folded.There was blood present in the guidewire lumen and within the balloon folds.Product analysis was unable to confirm the reported event as there was no damage to the tip of the device found in analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that tip damage occurred.The patient presented with coronary artery disease.A 2.50mm x 8mm nc emerge balloon catheter was selected for use in a percutaneous coronary intervention.However, during preparation, the catheter tip was bent and damaged.Another balloon was used to complete the procedure.No patient complications were reported.However; returned device analysis revealed shaft break.

• 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: 15186271
• Report Number: 2134265-2022-08208
• Device Sequence Number: 17795332
• Product Code: LOX
• UDI-Device Identifier: 08714729846246
• UDI-Public: 08714729846246
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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: 02/03/2024
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0028799350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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 Sex: Unknown