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

Model Number 45007

Device Problem Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the jetstream catheter aspiration did not work properly.A 2.4mm jetstream xc atherectomy catheter was selected to treat peripheral arterial disease.During the procedure, it was noted that the aspiration did not work properly as there was no blood in the tube for a long time.They went crossover and used the thruway 0.014.The procedure was completed successfully using another jetstream catheter.No patient complications were reported.

Event Description

It was reported that the jetstream catheter aspiration did not work properly.A 2.4mm jetstream xc atherectomy catheter was selected to treat peripheral arterial disease.During the procedure, it was noted that the aspiration did not work properly as there was no blood in the tube for a long time.They went crossover and used the thruway 0.014.The procedure was completed successfully using another jetstream catheter.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of a 2.4mm jetstream xc atherectomy catheter.The device was visually examined for any shaft damage and the functional testing of the device was completed.Visual inspection revealed no shaft damage.Functional analysis revealed the device primed and ran per design.Aspiration testing of the device was completed, and the test results revealed that this device performed as designed per the test procedure specification sheet.Inspection of the remainder of the device revealed no damage or irregularities.Analysis was not able to confirm the aspiration issues reported from the field.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18852028
• MDR Text Key: 337621512
• Report Number: 2124215-2024-12573
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0032135209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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