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

Model Number	7133
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.A 3.00mm x 15mm emerge balloon catheter was prepared, however, the stylet was stuck during removal and the tip broke.The procedure was completed with another of the same device.No complications nor harm were done to the patient.
Event or Problem Description
It was reported that tip detachment occurred.A 3.00mm x 15mm emerge balloon catheter was prepared, however, the stylet was stuck during removal and the tip broke.The procedure was completed with another of the same device.No complications nor harm were done to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 35.5cm proximal of the tip.There was no proximal portion of the device.The balloon was tightly folded.There were numerous sections of the outer shaft that were stretched down.The inner shaft was stretched for 19mm starting 46mm from the tip.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: 11114678
• Report Number: 2134265-2020-18487
• Device Sequence Number: 4050182
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 05/22/2023
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0026069901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1