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

Model Number 45007

Device Problems Entrapment of Device (1212); Suction Problem (2170); Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Device analysis by mfr: the returned product consisted of a jetstream xc 2.4 mm atherectomy catheter.Analysis of the device showed a lot of blood in the waste bag.No guidewire was stuck in the device when returned and due to the extreme damage on the shaft a guidewire could not be inserted.It was noticed that the catheter shaft was stuck on the sheath.The devices shaft showed buckling 2 cm and 79 cm from the tip.There was a kink located 64 cm from the tip.The device was connected to the jetstream console.The device was primed and activated and functioned as designed in all modes of blades up and blades down.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that the patient experienced a perforation which required surgical intervention.Two 2.4 mm jetstream xc catheters and a non-bsc guidewire were selected for an atherectomy procedure in the left superficial femoral artery (sfa).A 7 french 55 centimeter non-bsc sheath was used to gain access through a contralateral approach.The first jetstream device was advanced into the sheath over the non-bsc filter wire.The physician noted difficulty in advancing the device through the sheath.At this point the physician opted to remove the entire device and replace it with a new device.The second device was opened and inserted over the guidewire.One pass was made, approximately 15 centimeters, with the device in blades down mode until the device would go no further.At this point, the physician opted to rex the device backwards to position it proximal to the blockage.However, the device lost some rpms advancing.The return flow showed zero blood return into the waste bag, only the saline rotaglide mix was returning.While removing the device, it could not be entirely returned through the sheath.Approximately 1-2 centimeters of the jetstream catheter was hanging out of the sheath so the sheath was removed along with the device.After regaining access and visualizing the vessel, a perforation was noted in the common femoral artery.The patient was sent for surgical intervention and the case was ended.The patient was discharged from the hospital two days later.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9072446
• MDR Text Key: 159128478
• Report Number: 2134265-2019-11034
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: 08714729889922
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023442745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR