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

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left circumflex artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced and inflated successfully.However, when the device was removed, the delivery shaft was fractured.The device was completely removed and the procedure was completed with a different device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left circumflex artery.A 3.50mm x 15mm nc emerge balloon catheter was advanced and inflated successfully.However, when the device was removed, the delivery shaft was fractured.The device was completely removed and the procedure was completed with a different device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a emerge mr balloon catheter.The balloon was loosely folded with blood in the balloon shaft.Analysis of the tip, balloon, markerband, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed a complete separation at the shaft/hypotube bond (37.2 cm from the tip).Inspection of the rest of the device found no other damage or defect.

• 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: 10184748
• Report Number: 2134265-2020-07442
• Device Sequence Number: 2706897
• Product Code: LOX
• UDI-Device Identifier: 08714729846543
• UDI-Public: 08714729846543
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 12/19/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024962373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 70