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

Model Number 45007

Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6).Device evaluated by manufacturer: the device was returned for analysis consisted of a jetstream xc 2.4mm atherectomy catheter.The device was visually examined and it was noticed that there was shaft damage in the form of buckling/kinks located at 126cm from the tip proximal.The infusion line had burst proximal the buckling/kinks, located approximately 5cm to 16cm from the tip.Functional testing was unable to be performed due a severely damaged of the sheath.The damage that was noticed was consistent with sheath interference during the procedure or by pushing, pulling and torqueing of the device in a tortuous anatomy or a heavily calcified lesion.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 outer liner of the device peeled and difficulty removing occurred.A 2.4mm jetstream xc catheter was selected for an atherectomy procedure in the heavily calcified superficial femoral artery (sfa).During the procedure, the jetstream catheter had difficulty to cross the lesion.When the physician attempted to remove the device, he did not hit the rex button immediately and experienced resistance when removing the device from the patient.At that point, the physician hit the rex button and the device would not completely activate in rex and he had to remove the system from the patient without rex.The rex would not engage or advance the sheath.There was difficult to remove the catheter through the non-bsc sheath, it was pulled the sheath and catheter together.Upon visual inspection of the device, it was noticed that the clear protective covering at the distal end of the jetstream catheter had sheared and was prohibiting the catheter from being removed from the patient.The procedure was completed with a balloon angioplasty.There were no patient complications reported and the patient's status post procedure was stable.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9272972
• MDR Text Key: 168281055
• Report Number: 2134265-2019-13330
• 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: 11/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0023422100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1