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	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter with a 0.014" guidewire stuck in the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple minor kinks along the hypotube.The guidewire that is stuck in the device extends approximately 148.3cm from the tip.Microscopic examination revealed buckling to the balloon, inflation lumen, and guidewire lumen.The buckling starts at approximately 4mm from the tip and is approximately 31mm long.The tip is damaged.Review of the product specification indicates a 0.014" guidewire is compatible with an emerge balloon catheter therefore, there is no indication of a compatibility issue.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 the circumflex/obtuse marginal artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, it was noted that there was difficulty pulling the balloon over the wire.The device was removed together with the wire.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 8503758
• Report Number: 2134265-2019-03697
• Device Sequence Number: 1516283
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/11/2019

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: 07/26/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0023004627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1