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

Model Number 45007

Device Problems Entrapment of Device (1212); Connection Problem (2900)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

It was reported that guidewire entrapment occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.A 2.1/3.0mm jetstream xc catheter was selected for an endovascular therapy procedure to treat the peripheral arterial disease.The guidewire used with the jetstream was a thruway14 gw 014/300/5.The recommended sheath for using with the jetstream was defective, so a non-boston scientific 7 french introducer sheath was used.During removal after the procedure was completed, the thruway guidewire was found to be entrapped in the jetstream catheter.Since the treatment was already completed successfully with the devices, they were removed, and the procedure was ended with no adverse events.

Event Description

It was reported that guidewire entrapment occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.A 2.1/3.0mm jetstream xc catheter was selected for an endovascular therapy procedure to treat the peripheral arterial disease.The guidewire used with the jetstream was a thruway14 gw 014/300/5.The recommended sheath for using with the jetstream was defective, so a non-boston scientific 7 french introducer sheath was used.During removal after the procedure was completed, the thruway guidewire was found to be entrapped in the jetstream catheter.Since the treatment was already completed successfully with the devices, they were removed, and the procedure was ended with no adverse events.

Manufacturer Narrative

Device evaluated by manufacturer: the device returned to boston scientific consisted of a jetstream xc-2.1 atherectomy catheter.No guidewire was stuck in the device or returned with the device.The device was visually and microscopically examined for any shaft damage.Visual and microscopic examination showed no shaft damage.A test.014 thruway guidewire was inserted into the device with no hesitations or restrictions.The devices connector was inspection due to the alleged connection issue.It was noticed that a pin was bent in the connector which makes connection to the console impossible and functional analysis of the device cannot be completed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information.The complaint for a connection issue was confirmed; however, guidewire sticking issue was not confirmed.

• Brand Name: JETSTREAM XC
• 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 ; EI
• Manufacturer Contact: jeff wallner wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16869151
• MDR Text Key: 314893368
• Report Number: 2124215-2023-21583
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: 08714729889892
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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: 0030512577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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