MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER, PRODUCT CODE: NRY

Model Number ICRC071137

Device Problems Break (1069); Material Separation (1562)

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

Event Date 03/12/2023

Event Type  Injury  

Event Description

A 78-year-old female patient was found to have a clot in the left m1 segment.The patient reportedly had a heavy/dense plaque present in the distal ica and the occlusion was described as very "calcified.Access was obtained with a zoom 88 catheter, 5f competitor microcatheter, and guidewire.A zoom 71 catheter was introduced over the competitor microcatheter and advanced to the cavernous internal carotid artery (ica) through zoom 88.The zoom 88 was advanced to the cavernous ica.A stent retriever was then advanced through the zoom 88 and zoom 71 and through the clot in the left m1 segment.As the stent retriever was pulled into zoom 71, the physician experienced heavy resistance and found it very difficult to retract the stent retriever.The physician then attempted to pull the stent retriever and zoom 71 as a system into zoom 88 and again noticed very heavy resistance.During removal of the zoom 71 and stent retriever, the physician determined the distal section of the zoom 71 had separated.Imaging showed the distal segment of the zoom 71 inside the tip of the zoom 88.A vac-lock syringe was used to successfully pull the remaining zoom 71 from the zoom 88 and remove it from the patient.Keeping the zoom 88 in place, the physician performed a contrast run, which demonstrated reperfusion.The patient was reported as stable.No sequelae were reported.

Manufacturer Narrative

The zoom 71 catheter was returned for investigation.The investigation demonstrated severe damage to the catheter shaft; stretching, kinking, and separation of the shaft material; and damage to the shaft coil.However, the distal segment described by the physician was still connected to the catheter via the coil.Based on the information provided and device investigation the exact root cause could not be determined.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER, PRODUCT CODE: NRY
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell ave.; campbell, CA 95008-6609
• MDR Report Key: 16829080
• MDR Text Key: 314163014
• Report Number: 3014590708-2023-00011
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2233202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5 FR. PENUMBRA SELECT SIM2; MARKSMAN 27 MICROCATHETER; TERUMO GLIDEWIRE ADVANTAGE; TIGER STENT RETRIEVER; ZOOM 88
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female