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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem Vasoconstriction (2126)

Event Date 05/27/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced numerous spasms.A 2.1mm jetstream xc atherectomy catheter was selected for use.After three minutes of normal use, the catheter locked and there was a loss of aspiration.The patient experienced numerous spasms.The procedure was completed with another of the same device.The patient's status post procedure was stable.

Event Description

It was reported that the patient experienced numerous spasms.A 2.1mm jetstream xc atherectomy catheter was selected for use.After three minutes of normal use, the catheter locked and there was a loss of aspiration.The patient experienced numerous spasms.The procedure was completed with another of the same device.The patient's status post procedure was stable.It was further reported that the target lesion was located in the superficial femoral artery (sfa).The patient showed improvement post procedure; however, thrombosis occurred in two weeks.Visible defects were noted in the hoses.

Event Description

It was reported that the patient experienced numerous spasms.A 2.1mm jetstream xc atherectomy catheter was selected for use.After three minutes of normal use, the catheter locked and there was a loss of aspiration.The patient experienced numerous spasms.The procedure was completed with another of the same device.The patient's status post procedure was stable.It was further reported that the target lesion was located in the superficial femoral artery (sfa).The patient showed improvement post procedure; however, thrombosis occurred in two weeks.Visible defects were noted in the hoses.

Manufacturer Narrative

Device evaluated by mfr: the device returned to boston scientific consisted of a jetstream atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination revealed multiple buckling along the sheath.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10167921
• MDR Text Key: 195570328
• Report Number: 2134265-2020-08168
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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: 07/06/2021
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0024219581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 06/17/2021
• Supplement Dates FDA Received: 08/11/2020; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR