MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPIROFLEX ANGIOJET THROMBECTOMY SET; CATHETER, EMBOLECTOMY

Model Number 10706

Device Problem Entrapment of Device (1212)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

Event Description

It was reported that the guidewire was stuck.The 80% stenosed target lesion was located in the non-tortuous and severely calcified deep artery of the left lower extremity.An angiojet spiroflex was selected for thrombectomy procedure.During advancing, it was noted that the guidewire got stuck in the middle of the catheter.The guidewire was withdrawn and was replaced with a new guidewire; however, it was still stuck.Upon inspection, it was noted that the tubing part of the catheter was damaged and not smooth.The procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital device evaluated by mfr: the device was returned for evaluation.The product was returned to boston scientific for analysis.Returned product consisted of an angiojet spiroflex catheter.No guidewire was received with the device.An.014 test guidewire was used during the wire insertion test.The guidewire was inserted into the wire lumen at the tip and was unable to pass through the device at the guidewire lumen damage.No other issues were identified during the product analysis.

Event Description

It was reported that the guidewire was stuck.The 80% stenosed target lesion was located in the non-tortuous and severely calcified deep artery of the left lower extremity.An angiojet spiroflex was selected for thrombectomy procedure.During advancing, it was noted that the guidewire got stuck in the middle of the catheter.The guidewire was withdrawn and was replaced with a new guidewire; however, it was still stuck.Upon inspection, it was noted that the tubing part of the catheter was damaged and not smooth.The procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.

• Brand Name: SPIROFLEX ANGIOJET THROMBECTOMY SET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18875672
• MDR Text Key: 337334854
• Report Number: 2124215-2024-12499
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0031117015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 60 KG