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

Model Number 45007

Device Problems Break (1069); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that the infusion line broke and leaked during the procedure.The 99% stenosed target lesion was located in a mildly tortuous and severely calcified vessel of the lower extremity.A jetstream xc catheter, 2.1mm was selected for the atherectomy procedure to treat the peripheral arterial disease.During the procedure, however, as the device was advanced through the sheath, the physician was sprayed with a fluid mist.It appeared the outer layer of the jetstream xc catheter broke and was spraying saline when the device was activated.The portion that was compromised was still outside of the body at the time of the break.The device was removed intact as a whole unit and replaced with a device from a different batch.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.4 atherectomy catheter.The device was visually examined for any shaft damage.Visual and microscopic examination showed a kink/buckling located 49cm from the tip.The device showed a burst infusion sheath on the catheter shaft located 51cm to 53cm from the tip.The device was inserted into the console and set up per the ifu.The device ran as designed; however, the device leaked fluid during functional testing at the burst infusion sheath location.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of the device having shaft damage was confirmed.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15960727
• MDR Text Key: 307785388
• Report Number: 2124215-2022-50323
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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: 0029813712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male