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

Model Number	7134
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event of (b)(6) 2019 is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the balloon had deflation issue.A 2.50mm x 20mm emerge balloon was selected for use.At the end of the procedure, it was noted that the attachments to the indeflator seemed to slip off and not stay attached.Subsequently, the emerge balloon was not deflating easily.The device was successfully removed from the patient's body.No patient complications were reported.
Event or Problem Description
It was reported that the balloon had deflation issue.A 2.50mm x 20mm emerge balloon was selected for use.At the end of the procedure, it was noted that the attachments to the indeflator seemed to slip off and not stay attached.Subsequently, the emerge balloon was not deflating easily.The device was successfully removed from the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Date of event of (b)(6) 2019 is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was soaked in a water bath for 18 days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was able to inflate and deflate normally.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 9280621
• Report Number: 2134265-2019-13290
• Device Sequence Number: 14014389
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• 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,Followup
• Report Date (Section B): 12/16/2019

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 Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0024157592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1