MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM? XC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	112266-001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.A 2.4mm jetstream xc catheter was selected for a lower extremities (le) angiogram to treat peripheral artery disease (pad).When the outer package was opened, however, it was noted that the inner cover was not fully sealed, compromising the device sterility.An alternate jetstream device was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that contamination occurred.A 2.4mm jetstream xc catheter was selected for a lower extremities (le) angiogram to treat peripheral artery disease (pad).When the outer package was opened, however, it was noted that the inner cover was not fully sealed, compromising the device sterility.An alternate jetstream device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of a jetstream atherectomy system still in the shelf box.Visual examination revealed that the seal on the shelf box is open.The inner pouch was taken out, and it was confirmed to be open using the paper.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed that the seal on the pouch is open.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of a jetstream atherectomy system still in the shelf box.Visual examination revealed that the seal on the shelf box is open.The inner pouch was taken out, and it was confirmed to be opened using the paper.The tray was inspected and the seal for the tray appears to be incomplete.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed that the tray seal appears incomplete.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of quality control deficiency.
Event or Problem Description
It was reported that contamination occurred.A 2.4mm jetstream xc catheter was selected for a lower extremities (le) angiogram to treat peripheral artery disease (pad).When the outer package was opened, however, it was noted that the inner cover was not fully sealed, compromising the device sterility.An alternate jetstream device was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: JETSTREAM? XC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24455363
• Report Number: 2124215-2026-10685
• Device Sequence Number: 18678988
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271213(10)37935439
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K133023
• 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,Followup
• Report Date (Section B): 05/04/2026

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 Model Number: 112266-001
• Device Catalogue Number: 112266-001
• Device Lot Number: 0037935439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/08/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• 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