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

Model Number	45006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: article publication date used.Relationship between guidewire position and medial injury after use of jetstream for calcified femoropopliteal lesion natsumi yanaka 1, yotaro fujii 1, atsuya murai 1, yusuke setonaga 1, yuki kozai 1, toshihiko kishida 1, tomoya fukagawa 1, kohei yamaguchi 1, masafumi mizusawa 1, shigemitsu shirai 1, yohsuke honda 1, masakazu tsutsumi 1, shinsuke mori 1, norihiro kobayashi 1, masahiro yamawaki 1, yoshiaki ito 1.1: (b)(6) hospital.
Event or Problem Description
It was reported via literature that vessel perforation occurred.From march to november 2023, 13 lesions were treated using a jetstream sc device for calcified femoropopliteal lesions from outside of the calcified nodule.This study revealed the relationship between guidewire position and medial injury after use of jetstream for calcified femoropopliteal lesion.Results were as follows: the rate of medial injury was significantly higher in the opposite side to the nodule group (75% vs.0%, p=0.014).Conclusions: wire position beside the calcified nodule had less tendency of medial injury.

• 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 CORK LIMITED; 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: 20048791
• Report Number: 2124215-2024-48685
• Device Sequence Number: 7955713
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 45006
• Device Catalogue Number: 45006
• 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: 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• 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: Other
• Patient Sex: Unknown