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

Model Number	112264-001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterility was compromised.This 2.1mm jetstream? xc had no damage to the outer box; however, the packaging seal was broken, so the contents could be taken out.It was reported that the sterility of the device was compromised.There was no patient or procedure involvement.
Additional Manufacturer Narrative
Device eval 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 was cut open.The pouch appeared to still be sealed and undamaged.Inspection of the remainder of the device revealed no other damage or irregularities.The complaint was confirmed as the cut seal was consistent with the reported unsealed device packaging.
Event or Problem Description
It was reported that sterility was compromised.This 2.1mm jetstream? xc had no damage to the outer box; however, the packaging seal was broken, so the contents could be taken out.It was reported that the sterility of the device was compromised.There was no patient or procedure involvement.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23026751
• Report Number: 2124215-2025-63524
• Device Sequence Number: 18505425
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)270616(10)36534898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: Other
• Device Model Number: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0036534898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown