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

Model Number 112264-002

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter was punctured.A 2.1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery(sfa).During the procedure, the jetstream was used in the proximal sfa.The operator removed the catheter from the sheath due to a stiff feeling; the catheter could not be forwarded through the 7f sheath.They attempted to prime the catheter again, but the distal part of the catheter inflated during flushing.The coated surface of the catheter was punctured.There were no patient complications reported and the patient's status was reported as good.The procedure was completed with a different device.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter in one piece.The shaft and the remainder of the device were checked for damage.It was noticed that the shaft had buckling approximately 4cm from the tip.There was also a burst outer sheath approximately 6 to 7cm from the tip.When the inner sheath gets kinked damaged or buckled it restricts the fluid flow proximal of where the damage occurred.When the fluid is restricted it causes the outer sheath to swell and burst as it did in this case.Functional testing was done by completing the set up procedure and the device functioned; however, leaked at the burst point of the outer sheath.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 the catheter was punctured.A 2.1mm jetstream® xc atherectomy catheter was selected for an athrectomy procedure in the superficial femoral artery(sfa).During the procedure, the jetstream was used in the proximal sfa.The operator removed the catheter from the sheath due to a stiff feeling; the catheter could not be forwarded through the 7f sheath.They attempted to prime the catheter again, but the distal part of the catheter inflated during flushing.The coated surface of the catheter was punctured.There were no patient complications reported and the patient's status was reported as good.The procedure was completed with a different 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: 6490889
• MDR Text Key: 72806479
• Report Number: 2134265-2017-03448
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 112264-002
• Device Catalogue Number: PV31300
• Device Lot Number: 19362968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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
• Patient Age: 83 YR