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

Model Number 45007

Device Problem Difficult to Advance (2920)

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

Event Date 07/01/2021

Event Type  malfunction  

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 and microscopic examination revealed no damages.A test guidewire was attempted to be inserted into the tip but was unable to pass through.The tip was soaked in a water bath for several days but the obstruction was still present.The tip was cut off and a piece of foreign material was found inside.Ftir testing of the foreign material suggests that it is wool.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 06aug2021.It was reported that there was difficulty advancing the device over the wire.A 2.1mm jetstream xc catheter was selected for a patient procedure for a right superficial femoral artery occlusion.The catheter was used, and then removed so the physician could treat the lesion with another method.When they went to reinsert the jetstream catheter, it would not advance over the wire at the tip end.Another of the same device was used to complete the procedure with the same wire.However, device analysis revealed foreign material in the tip of the device.

• Brand Name: JETSTREAM XC
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12377416
• MDR Text Key: 268466839
• Report Number: 2134265-2021-10786
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133023
• 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
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2023
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0027087791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1