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

Model Number	7130
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft detachment occured.During preparation, while the physician placed the 1.5 x 8mm emerge balloon catheter on the guidewire, it was noted that the distal tip of the catheter was completely detached from the balloon.
Event or Problem Description
It was reported that shatf detachment occured.During preparation, while the physician placed the 1.5 x 8mm emerge balloon catheter on the guidewire, it was noted that the distal tip of the catheter was completey detached from the balloon.Returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that approximately 3mm of the tip is separated from the device.Microscopic examination revealed that the tip is damaged and the balloon is tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the tip is separated and appeared to be stretched prior to separation.

• 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: 7908378
• Report Number: 2134265-2018-61289
• Device Sequence Number: 1484966
• Product Code: LOX
• UDI-Device Identifier: 08714729806493
• UDI-Public: 08714729806493
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K121196
• 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): 10/19/2018

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: 01/04/2021
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0022104143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1