MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK JETSTREAM® XC ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 112266-003

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a jetstream xc-2.4 atherectomy catheter in one piece.Visual inspection of the device revealed that the shaft showed some damage.The shaft and the remainder of the device were inspected for damage.Visual examination showed that the shaft and infusion line were damaged with what looked like a kink approximately 50.5cm from the tip and a small hole approximately 56cm from the tip.The device functioned with no issues in the blades down mode and the blades up mode.Visual inspection during functional testing showed that the device was leaking fluid from the damage noticed on the catheter shaft.Microscopic investigation did show that the infusion line did have a small hole in it and the fluid was leaking from that area.With the kink distal to the hole this would restrict fluid flow to the tip of the catheter and would cause a back-up of fluid proximal to the kink which would eventually cause the infusion sheath to burst, which was the cause for the leaking issues on this device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that there was a loss of rotational speed and a catheter hole/leak occurred.A 2.4mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the totally occluded superficial femoral artery.Access was cross-over/upside-down.The first 2 cm had heavy calcified stenosis.The jetstream passed the first 2 cm and continued.Everything worked fine.A 20 cm later (approximately 7-8 mins runtime) the device hit in a very calcified lesion.The sound of the jetstream changed and it stopped rotating and did not work anymore.Neither front cutting nor backwards mode worked.The physician took the device out of the patient, the non-bsc guidewire remained in patient.There was no interacting between the guidewire and catheter.The physician tested the rotation again outside the patient; however it did not work.The physician carefully hit the tip of the jetstream catheter against the water bucket in the sterile table.After 3 or 4 hits the rotation worked again, but the aspirated water from the water bucket came out of a hole in the catheter and the physician could not see water going into the "bin bag".The hole is approximately 30 cm proximal from the tip.No error message was displayed.The procedure was completed with several ranger balloons for dilatation and 3 innova stents to treat the whole area.No patient complications were reported and the patient was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the guidewide remained in the patient and a ranger balloon and stents were guided via the remaining guidewire.After the final angiogram, the guidewire was removed.The unspecified 7 fr sheath was removed, then the entire hole was closed with a dedicated closure device.

• Brand Name: JETSTREAM® XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6572409
• MDR Text Key: 75346901
• Report Number: 2134265-2017-04658
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K130637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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: 02/28/2019
• Device Model Number: 112266-003
• Device Catalogue Number: PV41340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 06/22/2017
• Supplement Dates FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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
• Treatment: GUIDEWIRE- ABBOTT BARE WIRE
• Patient Age: 56 YR