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

Model Number	7212
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that labeling issue occurred.During unpacking of a 2.75mm x 12mm nc emerge balloon, it was noted that a 3.00mm x 12mm nc emerge was found inside the box instead.The procedure was completed and no patient complications were reported.
Event or Problem Description
It was reported that labeling issue occurred.During unpacking of a 2.75mm x 12mm nc emerge balloon, it was noted that a 3.00mm x 12mm nc emerge was found inside the box instead.The procedure was completed and no patient complications were reported.
Additional Manufacturer Narrative
D4: lot number updated from 0026110442 to 0025497152.D4: expiration date update from 10/01/2022 to 05/07/2022.D4: unique identifier (udi) update from (b)(4) to (b)(4).H4: device manufacture date update from 10/01/2020 to 05/07/2020.
Additional Manufacturer Narrative
D4: lot number updated from 0026110442 to 0025497152.D4: expiration date update from 10/01/2022 to 05/07/2022.D4: unique identifier (udi) update from (b)(4).H4: device manufacture date update from 10/01/2020 to 05/07/2020.Device evaluated by mfr.:returned product consisted of the box packaging to an nc emerge balloon catheter.The device returned was an nc emerge balloon catheter along with the matching inner tyvek packaging and shipping hoop.Photo media depicted packaging to both the box and the inner packaging with device.The box shows it was opened as well as the tyvek packaging where the seal on the back was opened to expose the device.The product pouch was visually inspected.The product pouch contained a unit which matched the tyvek packaging batch.The back packaging was torn open prior to being returned.The device was microscopically and visually examined.The device presented no sign of use past removal of packaging.No damage or irregularity to the balloon catheter was found.Inspection of the remainder of the packaging and device presented no damage.Operations engineering personnel reviewed the applicable manufacturing records related to the complaint device.There is no indication that the reported complaint is related to the manufacturing process.Product analysis found the device was not compatible with the box packaging returned at which time it was determined to use an ops memo for this event.Review of photo media provided was found to align with analysis.
Event or Problem Description
It was reported that labeling issue occurred.During unpacking of a 2.75mm x 12mm nc emerge balloon, it was noted that a 3.00mm x 12mm nc emerge was found inside the box instead.The procedure was completed and no patient complications were reported.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13971925
• Report Number: 2134265-2022-03738
• Device Sequence Number: 4792876
• Product Code: LOX
• UDI-Device Identifier: 08714729846383
• UDI-Public: 08714729846383
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2022

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: 05/07/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0025497152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/29/2022; 05/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/29/2022; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown