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

Model Number 45007

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

It was reported the catheter tip stopped spinning during use.A 2.4mm jetstream® xc atherectomy catheter was being used in a rotational atherectomy treatment procedure in the patients leg.While the physician was performing an atherectomy in a long lesion.Two passes with blades down were completed successfully.During the third pass with blades up (total run time so far 6 minutes), the catheter stopped turning while in the lesion.The catheter was removed from the patient.The catheter was re-primed and tested outside of the patient during which the control pod started making a strange noise.So the physician decided not to use the device in the patient any more and complete the procedure with a new catheter.No patient complications were reported and the patient was stable.

Event Description

It was reported the catheter tip stopped spinning during use.A 2.4mm jetstream xc atherectomy catheter was being used in a rotational atherectomy treatment procedure in the patient's leg to treat a long lesion.Two passes with blades down were completed successfully.During the third pass with blades up (total run time thus far 6 minutes), the catheter tip stopped spinning while in the lesion.The catheter was removed from the patient.The catheter was re-primed and tested outside of the patient during which the control pod started making a strange noise.The physician decided not to use the device in the patient any more and completed the procedure successfully with another jetstream catheter.There were no patient complications.

Manufacturer Narrative

Device technical analysis: returned product consisted of a jetstream xc-2.4 atherectomy catheter.The shaft and the remainder of the device were inspected for damage.Visual examination showed a severe kink at the strain relief.It was noticed that the waste bag line was cut by the customer site when the device was returned.A.014 test guidewire was inserted into the device but would not transcend through the device do to a dried blood occlusion at the tip area of the device.The device was set up per the dfu and the device would not rotate as designed.It was noticed that an obstruction was in the masticator window of the aspiration port.The obstruction looked to be a piece of the nitinol from a stent.If the device is run through a stent during the procedure and the stent had been damaged or had other deformities associated with it, it would be possible for the tip to interfere with the placed stent and cause the stent to fracture.It would be possible for a partial piece of the fractured stent to aspirate into the masticator window and stall the device.The obstruction was removed and sent for scanning electron microscope (sem) analysis to discover the material composition.After the obstruction was removed the device was again functionally tested.The rotation of the device made noises which are not inherent of the device.The device would start and stop and would never reach the designed speed.This is consistent with drive coil damage which was indicated by the severe kink at the strain relief.The device rotational issues was confirmed due to an obstruction.The sem analysis performed confirmed the metal to be consistent with nitinol metal.Review of the manufacturing records for batch 21775414 confirmed that there was a total of 45 units started for this manufactured batch with no rework or scrap.Review of the manufacturing records determined that all the 45 finished units were successfully processed.There were no non-conformances that occurred during the manufacturing process of this batch.It can be concluded that all the devices in this batch were manufactured per process and met all specifications.

• Brand Name: JETSTREAM XC ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; model farm road; maple grove MN 55311
• MDR Report Key: 7664293
• MDR Text Key: 113285327
• Report Number: 2134265-2018-05971
• 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
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: 45007
• Device Catalogue Number: 45007
• Device Lot Number: 0021775414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1