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

Model Number ICRC071137

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2022

Event Type  Injury  

Manufacturer Narrative

Zoom71 catheter was returned for investigation.Device investigation confirmed shaft separation at approximately 14 cm from the distal end of the catheter.The separated distal segment was observed to have a flattened marker band, exposed coil, extrusion and stretched liner.The separated proximal segment had multiple kinks and stretched extrusion on the distal end indicating retraction against resistance.Based on the location of the shaft separation (14cm) and the shape of the kink, it is possible that the separation occurred at the acute bend in the ica during retraction as it is suspected the catheter was pinned down at two locations (in the petrous and the acute bend in the proximal ica).Based on the information provided, the patient had tortuous anatomy with an acute bend in the proximal ica.Additionally, the physician indicated the zoom71 catheter got hung up in the "bad" stenosis present supraclinoid.The physician encountered resistance once zoom71 reached the supraclinoid and the catheter wouldn't advance further.Although access to the clot was obtained with a guidewire and zoom 71, the physician could not advance the tracstar ldp past the acute bend.Per zoom 71 instruction for use: "do not advance or withdraw the zoom catheter or accessory/adjunctive devices against resistance without careful assessment of cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation and torquing the device against resistance may result in damage to the vasculature or the device" and "do not use kinked devices." the manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed to ensure the device met minimum tensile specification and is kink resistant.The distal section undergoes 100% visual inspection and is free of visual defects.

Event Description

The patient was being treated for an occlusion at the right internal carotid artery (ica) mi terminus segment.The patient reportedly had a tortuous anatomy with an acute bend noted in the proximal ica.A quick access was obtained with the guidewire, tracstar ldp and zoom71.Tracstar was parked just before the proximal acute bend and did not go beyond this bend.The physician encountered resistance once zoom71 reached the supraclinoid and the catheter wouldn't advance further.There was a "bad" stenosis there and the physician felt the zoom71 catheter got hung up in the stenosis.Primary aspiration was made with the zoom71 with a result of tici 2b.During removal of the zoom71, the catheter separated 14mm from the distal end and remained in the right ica.Visual confirmation was made on fluoroscopy, and multiple attempts were made to remove the distal portion of the zoom71 but were unsuccessful.The patient was referred to vascular surgery and a cut down of the right ica was performed.The distal portion of the catheter was successfully removed.During post cut down, angiography showed a clot in the distal ica.Tracstar ldp 95cm, zoom55, competitor microcatheter, and stent retriever were used through the existing groin access to remove the clot successfully.Angiographic result showed tici 2c after second pass.Next day post procedure, patient's care was withdrawn, and the patient passed away three days later.Per the account, death was the result of age and having a "really bad stroke".

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 13779489
• MDR Text Key: 288480012
• Report Number: 3014590708-2022-00004
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• 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: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2131201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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
• Treatment: .014 GUIDEWIRE; 8F SHORT SHEATH; SOLITAIRE 4 X 20; SYNCHRO SUPPORT; TRACSTAR LDP 95CM; VELOCITY; ZOOM 55
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 78 KG