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

Model Number 45007

Device Problem Device-Device Incompatibility (2919)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2023

Event Type  Injury  

Event Description

It was reported that the ptfe coating of a non-boston scientific covered stent was removed during use of a jetstream.A 2.4mm jetstream xc atherectomy catheter was selected for this transluminal angioplasty procedure.During the procedure, it was noted that the ptfe coating of a non-boston scientific stent was removed when the jetstream blade passed through.The coating was too big to be aspirated.The stent remains implanted and no further intervention was performed.The procedure was completed successfully without sequelae.

Event Description

It was reported that the gore viabahn stent ptfe coating was removed by the jetstream blade.A 2.4mm jetstream xc atherectomy catheter was selected for this transluminal angioplasty procedure.During the procedure, it was noted that gore viabahn stent ptfe coating was removed when the jetstream blade passed through.The coating was too big to be aspirated.The stent remains implanted and no further intervention was performed.The procedure was completed successfully without sequelae.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: 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 ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16894619
• MDR Text Key: 314816021
• Report Number: 2124215-2023-21761
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0028176659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 100 KG
• Patient Race: White