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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection results of the returned device confirmed that the distal section of the catheter was separated.The returned device detached at 0.4 cm from the distal tip, and the remaining shaft measured at 137.8cm.The detached portion includes a slightly folded marker band, stretched jacket material, and coil.A kink was present at 15.0cm from the tip of the remaining shaft.It is uncertain if this kink was present during the procedure or was a result of handling damage after removal from the patient.Based on provided case information, resistance was encountered, and the zoom 71 continued to be retracted against resistance.If the device is constrained and forcefully retracted against resistance, the device may stretch and detach.The root cause of the resistance and detachment is unable to be determined as the provided case images did not capture the pertinent vessel anatomy at moment of detachment.Per instructions for use, the devices should not be withdrawn against resistance without careful assessment of the cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection was 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 or protrusions.This report is associated with mfr report number: 3014590708-2020-00007.
Event or Problem Description
The patient was undergoing a thrombectomy procedure on (b)(3) to treat occlusion within the mid basilar artery.Patient displayed underlying atherosclerosis at the occlusion site.Access was obtained at the distal vertebral artery using the zoom 88t 110cm which was advanced over a competitor angiographic catheter and a 035 guidewire.Zoom 71 reperfusion catheter was subsequently advanced unsupported to the site of the occlusion and some clot was removed through the zoom 71 catheter.A total of two passes were performed.Zoom 71 was pulled into zoom 88 (tip still intact) with resistance seen on withdrawal.The tip separated inside zoom 88 but was not noticed by the physician.Competitor devices were used to retrieve more clot and physician saw the tip in the vertebral artery.Tip was removed using stent retriever and competitor intermediate catheter.The physician proceeded to perform angioplasty to address the mid basilar atherosclerosis with no further issues.The case was completed with no additional clinical event.Patient was noted to be stable post operation.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell CA 95008 6609
• MDR Report Key: 10909469
• Report Number: 3014590708-2020-00006
• Device Sequence Number: 2127610
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: (01)00812212030191(17)210710(10)V2014901
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202182
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: V2014901
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention