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

Model Number	7143
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device sterility was compromised.On checking inventory, a 2.00mm x 15mm emerge balloon catheter was noted to have its inner package not properly sealed along one full side of the package and was completely open compromising the sterility of the device.The device itself was not damaged.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The product pouch was visually inspected.The product pouch contained a unit for batch 26230247 and there was no bsc seal.The batch number on the returned packaging was 26230247.The tyvek seal was inspected, and it was still intact.Operations engineering was contacted to verify the missing seal and it was agreed that the packaging was not sealed when it left manufacturing facility.Inspection of the remainder of the packaging and device presented no other damage or irregularities.Product analysis found there was an open seal.
Event or Problem Description
It was reported that device sterility was compromised.On checking inventory, a 2.00mm x 15mm emerge balloon catheter was noted to have its inner package not properly sealed along one full side of the package and was completely open compromising the sterility of the device.The device itself was not damaged.

• 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: 11337623
• Report Number: 2134265-2021-01449
• Device Sequence Number: 3483710
• Product Code: LOX
• UDI-Device Identifier: 08714729806806
• UDI-Public: 08714729806806
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 10/22/2022
• Device Model Number: 7143
• Device Catalogue Number: 7143
• Device Lot Number: 0026230247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1