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

Model Number	ICRC071137
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported information does not suggest a device malfunction, and the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the left m1 segment of the middle cerebral artery (mca).The imperative care zoom 071 reperfusion catheter was delivered over a stryker synchro2 014 guidewire and penumbra 3max reperfusion catheter to the site of the occlusion.The synchro2 and 3max were removed, then aspiration was started though the zoom 071.Successful revascularization of the vessel was confirmed on the post aspiration contrast run, but active extravasation was noted in the m1 mca region near the site of the clot.As the zoom 071, 3max, and synchro2 014 guidewire were all advanced to the clot site, it is possible one of the devices caused the extravasation.To address the extravasation, the physician used a scepter xc balloon catheter to occlude the m1 mca and administered medication.Patient was doing well post treatment and discharged from the hospital two days post procedure.
Additional Manufacturer Narrative
Results: the returned zoom 071 reperfusion catheter displayed no stretching or damage within the distal segment of the catheter.The atraumatic distal tip was measured within specification, with no ovalization, tears, jagged edges, malformation of marker band, or extruding coil.Conclusion: inspection of the returned device found no damage or abnormalities that would have contributed to the complaint of extravasation near the occlusion site in the m1 middle cerebral artery (mca).The concomitant medical products were not available for return and thus can not be evaluated.Imperative care catheters are visually inspected during in-process and quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to the design, manufacture, and quality.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occlusion in the left m1 segment of the middle cerebral artery (mca).The imperative care zoom 071 reperfusion catheter was delivered over a stryker synchro2 014 guidewire and penumbra 3max reperfusion catheter to the site of the occlusion.The synchro2 and 3max were removed, and then aspiration was started through the zoom 071.Successful revascularization of the vessel was confirmed on the post aspiration contrast run, but active extravasation was noted in the m1 mca region near the site of the clot.As the zoom 071, 3max, and syncrho2 014 guidewire were all advanced to the clot site, it is possible one of the devices caused the extravasation.To address the extravasation, the physician used a scepter xc balloon catheter to occlude the m1 mca and administered medication.Patient was doing well post treatment and discharged from the hospital two days post procedure.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER, PRODUCT CODE: NRY
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell, ca CA 95008 0412
• MDR Report Key: 9572417
• Report Number: 3014590708-2019-00002
• Device Sequence Number: 10858086
• Product Code: NRY
• UDI-Device Identifier: 00812212030061
• UDI-Public: (01)00812212030061(17)200215(10)V1922801
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K183043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2020
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: V1922801
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENUMBRA INC 3MAX REPERFUSION CATHETER; PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; STRYKER NEUROVASCULAR SYNCHRO2 MICRO GUIDE WIRE; STRYKER SYNCHRO2 MICRO GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR