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

Model Number	7134
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.After a guide wire crossed the lesion, a 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, the balloon was withdrawn along with the guide wire during the procedure.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed no additional damages.The balloon is loosely folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.A test guide wire was advanced into the guide wire lumen and was unable to advance all the way through.
Event or Problem Description
It was reported that catheter entrapment occurred.After a guide wire crossed the lesion, a 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, the balloon was withdrawn along with the guide wire during the procedure.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 8160993
• Report Number: 2134265-2018-63957
• Device Sequence Number: 2120094
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: 02/24/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0022321485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 60