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

Catalog Number	106608-001
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12828467
• Report Number: MW5105369
• Device Sequence Number: 4264094
• Product Code: MCX
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 106608-001
• Device Lot Number: 2804139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White