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

Model Number	7138
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary vessel.A 1.20mm x 15mm emerge push balloon catheter was advanced for dilatation.However, the device became stuck with the non-bsc guide wire.The device could not be advanced nor could be pulled out from the wire.Both devices were removed together from the patient's body.The procedure was completed with a new wire and a new balloon.No patient complications were reported.
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, inflation lumen, and core wire.Microscopic examination revealed that the tip is damaged.There is blood present in the guidewire lumen and the balloon is still tightly 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.014 inch test guide wire was advanced into the guide wire lumen and was able to pass through.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary vessel.A 1.20mm x 15mm emerge push balloon catheter was advanced for dilatation.However, the device became stuck with the non-bsc guide wire.The device could not be advanced nor could be pulled out from the wire.Both devices were removed together from the patient's body.The procedure was completed with a new wire and a new balloon.No patient complications were reported.

• Brand Name: EMERGE PUSH
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8302101
• Report Number: 2134265-2019-00660
• Device Sequence Number: 59299
• Product Code: LOX
• UDI-Device Identifier: 08714729806004
• UDI-Public: 08714729806004
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130391
• 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): 03/01/2019

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: 05/05/2021
• Device Model Number: 7138
• Device Catalogue Number: 7138
• Device Lot Number: 0022624583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: INTUITION (MEDTRONIC); GUIDE WIRE: INTUITION (MEDTRONIC); GUIDE WIRE: INTUITION (MEDTRONIC)
• Patient Age: 63 YR