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

Model Number	6534
Medical Device Problem Codes	Material Rupture (1546); Wrong Label (4073)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a labeling issue occurred.During a procedure, following rotablation, a device with package label of nc quantum apex 2.5 x 30mm was selected for use.However, the inner package contained a 3.5 x 30mm nc quantum apex in size.The oversized device resulted in a coronary perforation.The perforation was covered with a non-bsc stent.The patient was stabilized and expected to fully recover.
Event or Problem Description
It was reported that a labeling issue occurred.During a procedure, following rotablation, a device with package label of nc quantum apex 2.5 x 30mm was selected for use.However, the inner package contained a 3.5 x 30mm nc quantum apex in size.The oversized device resulted in a coronary perforation.The perforation was covered with a non-bsc stent.The patient was stabilized and expected to fully recover.
Additional Manufacturer Narrative
Correction: h6: removal of incorrect code.The device was not returned for investigation.However, two images were provided.The first image shows an image of the inner pouch label.This label highlights that the product size is a 3.5 x 30mm with a batch number listed as 31898685.The second image shows an outer box peel-off label.This label highlights that the product size is a 2.5 x 30mm with a batch number listed as 31491040.An investigation into each batch identified that there was no opportunity for a product mix-up to have occurred at their time of manufacture as they were not manufactured around the same dates: batch number listed as 31898685 started manufacture on the 26th june 2023.Batch number listed as 31491040 started manufacture on the 25th april 2023.Device analysis can confirm from a review of the photo images that the inner pouch label product size does not match the product size as indicated in the outer box peel-off label.However, as the cause could not be established, it is possible that at the hospital facility the nc quantum apex 2.5 x 30mm box had been opened and the device inside was removed (potentially used in another case) and that the box associated with the nc quantum apex 3.5 x 30mm box had also been opened and the inner sealed pouch containing the device was removed and was decided not to be used.It is likely that the 3.5 nc quantum apex was incorrectly placed back in the wrong box (the 2.5 nc quantum apex), resulting in this complaint event.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19644072
• Report Number: 2124215-2024-40225
• Device Sequence Number: 15386994
• Product Code: LOX
• UDI-Device Identifier: 08714729783572
• UDI-Public: 08714729783572
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0031491040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown