MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA THROMBECTOMY CATHETER - SPIROFLEX VG; CATHETER, CORONARY, ATHERECTOMY

Catalog Number 106608-001

Device Problems Break (1069); Fracture (1260)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

During the emergent left heart cath (stemi), the physician requested an angiojet spiroflex vg catheter: the first angiojet spiroflex vg catheter was dropped in sterile fashion, the console was prepared correctly by the circulating rn.The scrub tech handed off the pump and tubing to the circulating rn.The pump was correctly loaded into the console.The console correctly identified the type of catheter being used (spiroflex vg).The scrub tech followed the prompts on the screen of the console.The scrub tech attempted to prime the catheter for 10 seconds, however the catheter prime failed after 4 seconds.Staff attempted to repeat these steps 4 more times.The angiojet console then prompted to replace the catheter.The second spiroflex vg catheter was dropped in sterile fashon, the console was prepared correctly by the circulating rn.The scrub tech handed off the pump and tubing to the circulating rn.The pump was correctly loaded into the console.The console correctly identified the type of catheter being used (spiroflex vg).The scrub tech followed the prompts on the screen of the console.The scrub tech attempted to prime the catheter for 10 seconds and was successful.Upon loading the catheter onto the wire, prior to insertion into the body, it was noticed that the catheter was broken/fractured and fluid was leaking around the catheter shaft.The catheter was immediately removed and no other attempts were made in using the catheters.The patient was not harmed and another treatment device was chosen by the physician.Fda safety report id# (b)(4).

• Brand Name: ANGIOJET ULTRA THROMBECTOMY CATHETER - SPIROFLEX VG
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12828467
• MDR Text Key: 281018840
• Report Number: MW5105369
• Device Sequence Number: 2
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 106608-001
• Device Lot Number: 2804139
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White