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

Model Number 45007

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: (b)(6).

Event Description

It was reported that the outer layer of the catheter had peeled away.A 2.1mm jetstream xc was selected for use in an atherectomy procedure within the superficial femoral artery (sfa).A 7fr x 45cm non-boston scientific introducer sheath and a 0.014in x 300cm thruway guidewire were used during this procedure.While treating the distal right sfa, the outer layer of the jetstream xc was noted to have peeled away.The device was unable to be advanced into the sheath for treatment.The device was removed using rex mode.The procedure was completed using drug-coated balloons.No patient complications were reported, and the patient had a good result/outcome.

Manufacturer Narrative

A2: date of birth: (b)(6) 1948.Device eval by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage.Visual examination revealed that the baton and electrical connections were severed by the customer.There was shaft damage in the form of buckling/kinks.The location of the damage was 66cm to 68cm from the tip.There was also a kink/buckled area 1cm from the tip.Visual examination revealed that the infusion line had burst proximal to the buckling/kink damage.The location of the burst infusion line was approximately 72cm to 74cm from the tip.The device could not be functionally tested due to the baton and the electrical components being cut from the pod.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of the device having shaft damage was confirmed.

Event Description

It was reported that the outer layer of the catheter had peeled away.A 2.1mm jetstream xc was selected for use in an atherectomy procedure within the superficial femoral artery (sfa).A 7fr x 45cm non-boston scientific introducer sheath and a 0.014in x 300cm thruway guidewire were used during this procedure.While treating the distal right sfa, the outer layer of the jetstream xc was noted to have peeled away.The device was unable to be advanced into the sheath for treatment.The device was removed using rex mode.The procedure was completed using drug-coated balloons.No patient complications were reported, and the patient had a good result/outcome.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11037129
• MDR Text Key: 222344033
• Report Number: 2134265-2020-18101
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024218439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 01/19/2021
• Patient Sequence Number: 1
• Treatment: COOK MEDICAL INTRODUCER ANSEL MODIFICATION; COOK MEDICAL INTRODUCER ANSEL MODIFICATION; COOK MEDICAL INTRODUCER ANSEL MODIFICATION
• Patient Age: 72 YR