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

Model Number 45007

Device Problems Entrapment of Device (1212); Stretched (1601); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that guidewire entrapment occurred.The target lesions were located in the mid superficial femoral artery (sfa) just distal to a previously placed stent and in the distal sfa and popliteal artery.A 2.1 mm jetstream xc catheter was selected for an atherectomy procedure.The physician crossed the lesions and placed a non-boston scientific (bsc) filter wire just above the trifurcation.A non-bsc filter was placed over the wire.Then the jetstream catheter was advanced to treat both of the lesions.Two passes were made with blades down follow by a blades-up pass in the distal stent.No significant resistance was felt.The wire was removed from the gard and rexed back to then address the more proximal lesion.Two passes were made with blades down followed by a pass with blades up.The wire was removed from the gard and rexed out until it reached the sheath, then the pin and pull technique was used after that.It was noted that resistance was felt right before the device exited the sheath.While removing the device off of the wire outside of the body, resistance was encountered.The device ultimately became completely stuck on the last 5-10cm of the non-bsc wire.It was attempted to get the wire out of the catheter using forceps, but to no avail.The catheter was completely stuck on the wire and would not budge.The physician ended up cutting the wire just proximal to the jetstream burr.It was noted that the sheath had stretched due to the force used to try to remove it from the wire.The physician then went over that same wire that was cut outside of the body to retrieve the filter which was intact.The damaged wire was removed and replaced with a new wire, and the procedure was continued by treating the lesion with a ranger drug-coated balloon.The proximal lesion was also treated with another drug-coated balloon.The end result was great, and the physician was satisfied with the overall result.There was no harm to the patient, and nothing was left inside the patient.

• Brand Name: JETSTREAM XC
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17939149
• MDR Text Key: 325725176
• Report Number: 2124215-2023-56946
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0031845716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female