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

Model Number	7133
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and device detachment occurred.A 3.00mm x 15mm emerge balloon catheter was advanced in a previously placed stent.However, resistance was felt when the physician pulled the device back.When the balloon was checked for reusage, it was observed that the balloon material was missing.No patient complications were reported and patient's status was fine.
Event or Problem Description
It was reported that removal difficulties and device detachment occurred.A 3.00mm x 15mm emerge balloon catheter was advanced in a previously placed stent.However, resistance was felt when the physician pulled the device back.When the balloon was checked for reusage, it was observed that the balloon material was missing.No patient complications were reported and patient's status was fine.It was further reported that the tough-angled target lesion was located in a crushed stent in the mid right coronary artery.The balloon material was left inside the patient's body and was not retrieved.The procedure was completed with a different device.

• Brand Name: 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: 10254812
• Report Number: 2134265-2020-08550
• Device Sequence Number: 16788663
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024975956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other