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

Model Number	6534
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.When a 30mm x 3.00mm nc quantum apex balloon catheter arrived, it was noted that the balloon as well as the inner packaging were crushed and damaged.No patient complications were reported.
Additional Manufacturer Narrative
Correction: h6 device codes packaging problem (a0205) has been added.Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter, a shipping mandrel, balloon protector, shipping hoop, inner tyvek packaging, instructions for use (ifu) booklet, and outer box packaging.The outer shelf box was returned with an opened closure strip and a puncture going all the way through the box and its contents.The tyvek packaging and ifu booklet were then removed from the outer box.Upon inspection both were found to be punctured all the way through with no further damages.The tyvek packaging was returned unopened and was then unsealed to analyze the returned device.There was device damage visible prior to opening the tyvek packaging.The shipping hoop was damaged and separated twice at the puncture point of the packaging.The hoop was unwrapped to aid in device removal.There was no resistance during device removal.The device was visually and microscopically examined.There was separation of the hypotube just distal to the strain relief.The hypotube was flattened and bent for 4mm in length.At 55.7cm from the strain relief, the hypotube was flattened and bent for a length of 4mm.The balloon was tightly folded and there was no evidence of fluid within the device.Product analysis confirmed the reported packaging damage, device damage, and sterility as there was a puncture to the outer box, tyvek packaging, ifu booklet, and the hypotube of the device was found to be separated, flattened, and kinked.The shipping hoop was also separated and damaged.
Event or Problem Description
It was reported that device contamination occurred.When a 30mm x 3.00mm nc quantum apex balloon catheter arrived, it was noted that the balloon as well as the inner packaging were crushed and damaged.No patient complications were reported.

• Brand Name: NC QUANTUM APEX
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16246593
• Report Number: 2124215-2023-01915
• Device Sequence Number: 17720269
• Product Code: LOX
• UDI-Device Identifier: 08714729783596
• UDI-Public: 08714729783596
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• 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): 03/17/2023

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: 10/13/2025
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0030343214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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