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

Model Number 112264-002

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the outer coating of the device "melted" and a saline bubble formed.An antegrade approach was used to access the lesion.A 2.1mm jetstream xc atherectomy catheter was advanced over a non-bsc guidewire through a 7f 11cm super sheath.There was a kink in the introducer sheath.The jetstream performance was not affected.After the procedure during removal, the outer coating of the jetstream device was noted to be "melted" possibly due to the area of friction at the kink in the sheath.A saline bubble was created.No heat was present.The procedure was completed with this device.There were no patient complications and the patient condition was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream atherectomy catheter.The device was damaged from the customer site.The aspiration tubing and the electrical cords have been severed from the device.This device is non- functioning due to the extreme damaged caused by the customer.Testing the device due to the extreme damage is impossible.It was noticed that a kink was in the catheter shaft approximately 3cm from the tip.Visual examination did show the catheter shaft infusion sheath had ruptured approximately 8cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the outer coating of the device "melted" and a saline bubble formed.An antegrade approach was used to access the lesion.A 2.1mm jetstream® xc atherectomy catheter was advanced over a non-bsc guidewire through a 7f 11cm super sheath.There was a kink in the introducer sheath.The jetstream performance was not affected.After the procedure during removal., the outer coating of the jetstream device was noted to be "melted" possibly due to the area of friction at the kink in the sheath.A saline bubble was created.No heat was present.The procedure was completed with this device.There were no patient complications and the patient condition was stable.

• 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: 6187696
• MDR Text Key: 62793717
• Report Number: 2134265-2016-11931
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

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: 05/31/2018
• Device Model Number: 112264-002
• Device Catalogue Number: PV31300
• Device Lot Number: 19410354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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: 70 YR
• Patient Weight: 73