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

Model Number 112264-001

Device Problem Aspiration Issue (2883)

Patient Problem Thrombosis (2100)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a loss of aspiration and thrombus occurred.A 2.1 mm jetstream® xc atherectomy catheter was selected for use in an atherectomy procedure in the superficial femoral artery.Midway through the procedure, aspiration stopped working.The vessel clotted.Another jetstream, some medications and some angioplasty were used to resolve the issue.The patient was doing okay after the procedure.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter.The device was visually examined for any shaft damage and also functionality of the device.Functional analysis was done by completing the aspiration testing.The device is tested by using a 100ml beaker of water.The devices tip is submerged in a beaker of fluid and the device is run for a period of 1 minute.The final milliliters of fluid that the beaker shows is subtracted from the starting milliliters and the final number is the total that was aspirated (100ml¿ 89ml = 11ml).Test results showed that the device did not perform as designed per the test procedure specification sheet withdrawing 11ml of fluid in the 1 minute time frame.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Dissection of the catheter shaft showed that the aspiration lumen was occluded with a heavy clot burden which contributed to the aspiration issues.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was further reported that no error message occurred.Following the aspiration issue, the device was re-primed and advanced back into the patient to aspirate the clot.Aspiration was still not working well.At this point the physician chose to use a new device for aspirating the clot.There was no physical catheter issue.

• 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: 7159735
• MDR Text Key: 96224021
• Report Number: 2134265-2017-12792
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130637
• 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,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2019
• Device Model Number: 112264-001
• Device Catalogue Number: PV31300
• Device Lot Number: 21247941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR