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

Model Number	7132
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package was not sealed up.During preparation of a 1.50mm x 12mm emerge balloon catheter, it was noticed that the bottom end of the package was opened.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a pouch for an emerge balloon catheter.The product pouch was visually inspected.The product pouch contained a unit and there had no bsc seal.The tyvek seal was inspected, and it was still intact.Inspection of the remainder of the packaging presented no other damage or irregularities.
Event or Problem Description
It was reported that the package was not sealed up.During preparation of a 1.50mm x 12mm emerge balloon catheter, it was noticed that the bottom end of the package was opened.The device was not used and 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: 9306366
• Report Number: 2134265-2019-13430
• Device Sequence Number: 16687402
• Product Code: LOX
• UDI-Device Identifier: 08714729806073
• UDI-Public: 08714729806073
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0024177694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1