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

Model Number	7212
Medical Device Problem Codes	Contamination (1120); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon came out of the package occurred.A 3.00mm x 12mm nc emerge balloon catheter was prepared, however, it was observed that the packaging was damaged and balloon came out of the inner package with the tip poking out.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon came out of the package occurred.A 3.00mm x 12mm nc emerge balloon catheter was prepared, however, it was observed that the packaging was damaged and balloon came out of the inner package with the tip poking out.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter and its originally shipped packaging and outer box.The returned outer box was visually inspected with no damage present past opening of the box.The product pouch was visually inspected.The product pouch contained a unit for batch 27144786 which matched the returned packaging.The tyvek seal was visually inspected.The bottom tyvek (white) seal was pulled and curled up on the back flap of the packaging far enough that the device was visibly capable of being exposed out of the package.However, all seals on the package were complete and sealed at one point without error.Operations engineering was contacted for verification.Inspection of the remainder of the device, apart form the observed damage to packaging, revealed no other damage or irregularities.The complaint of the device having packaging damage was confirmed.Photo media reviewed matched analysis of device.

• 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: 12576335
• Report Number: 2134265-2021-12422
• Device Sequence Number: 3488407
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 04/15/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027144786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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