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

Model Number	112260-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jetstream catheter and the wire became stuck.A 1.6 mm jetstream sc atherectomy catheter was selected for percutaneous transluminal angioplasty treatment of the right superficial femoral artery.The lesion was 3 cm with severe calcification (95 percent stenosis) and moderate tortuosity.After passing the lesion with a non-boston scientific guidewire, the physician tried to use a microcatheter to replace the wire with a thruway recommended for use with jetstream.Unfortunately, the microcatheter did not pass through the lesion, so they had no choice but to continue without the thruway.After cutting about 90 percent of the lesion, the non-boston scientific wire began to pull forward, and eventually the catheter and wire became stuck and were removed together.The procedure was completed with another jetstream and drug-coated balloon without sequelae.
Additional Manufacturer Narrative
Device eval by manufacturer: this jetstream sc atherectomy catheter was returned for analysis and was visually and microscopically examined for any damage.Visual examination and microscopic examination revealed no damages.Inspection of the remainder of the device revealed no damage or irregularities.Product analysis confirmed the device is stuck on a guidewire.The reported guidewire that was used with this case was not listed as compatible per the instructions for use (ifu).
Event or Problem Description
It was reported that the jetstream catheter and the wire became stuck.A 1.6 mm jetstream sc atherectomy catheter was selected for percutaneous transluminal angioplasty treatment of the right superficial femoral artery.The lesion was 3 cm with severe calcification (95 percent stenosis) and moderate tortuosity.After passing the lesion with a non-boston scientific guidewire, the physician tried to use a microcatheter to replace the wire with a thruway recommended for use with jetstream.Unfortunately, the microcatheter did not pass through the lesion, so they had no choice but to continue without the thruway.After cutting about 90 percent of the lesion, the non-boston scientific wire began to pull forward, and eventually the catheter and wire became stuck and were removed together.The procedure was completed with another jetstream and drug-coated balloon without sequelae.

• Brand Name: JETSTREAM SC
• 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: 21266150
• Report Number: 2124215-2025-04465
• Device Sequence Number: 19743301
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: 08714729889830
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: Health Professional
• Device Expiration Date: 10/23/2025
• Device Model Number: 112260-001
• Device Catalogue Number: 112260-001
• Device Lot Number: 0032489713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND GUIDEWIRE; COMMAND GUIDEWIRE
• Patient Sex: Unknown