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

Model Number	112266-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device became stuck on the guidewire.The 70% stenosed and moderately calcified target lesion was located in the superficial femoral artery (sfa).A 2.4mm jetstream? xc catheter was selected for a lower extremity (le) angiogram and atherectomy procedure to treat peripheral artery disease (pad) in the sfa.Boston scientific's rotaglide atherectomy lubricant was used with the jetstream? xc catheter.During the procedure, the jetstream? xc catheter could not be removed, and the device became entrapped on the unknown-brand guidewire.Both the jetstream? xc catheter and the unknown-brand guidewire had to be removed together as one unit.An alternate device was used to complete the procedure.The unknown-brand guidewire was able to be removed from the jetstream? xc catheter once outside of the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: inspection of the returned jetstream revealed a kink.The complaint was confirmed as the kink is consistent with the reported difficult to remove and stuck on wire.Device evaluation by manufacturer: the returned product that was received by boston scientific consisted of a jetstream atherectomy catheter.Visual and microscopic inspection was completed.Visual examination revealed multiple kinks.Microscopic examination revealed no additional damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a kink on the sheath.Device history record (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 investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'cause linked to device but unable to trace more specifically.
Event or Problem Description
It was reported the device became stuck on the guidewire.The 70% stenosed and moderately calcified target lesion was located in the superficial femoral artery (sfa).A 2.4mm jetstream? xc catheter was selected for a lower extremity (le) angiogram and atherectomy procedure to treat peripheral artery disease (pad) in the sfa.Boston scientific's rotaglide atherectomy lubricant was used with the jetstream? xc catheter.During the procedure, the jetstream? xc catheter could not be removed, and the device became entrapped on the unknown-brand guidewire.Both the jetstream? xc catheter and the unknown-brand guidewire had to be removed together as one unit.An alternate device was used to complete the procedure.The unknown-brand guidewire was able to be removed from the jetstream? xc catheter once outside of the patient.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 LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24397047
• Report Number: 2124215-2026-09450
• Device Sequence Number: 21322708
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC ROTAGLIDE ATHERECTOMY LUBRICANT; BOSTON SCIENTIFIC ROTAGLIDE ATHERECTOMY LUBRICANT; UNKNOWN-BRAND GUIDEWIRE; UNKNOWN-BRAND GUIDEWIRE
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 88 KG