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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQGUIDE STEERABLE SHEATH STEERABLE CATHETER

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ACUTUS MEDICAL, INC. ACQGUIDE STEERABLE SHEATH STEERABLE CATHETER Back to Search Results
Model Number 900002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fistula (1862)
Event Date 04/08/2019
Event Type  Injury  
Manufacturer Narrative
It is not known what caused the arteriovenous fistula. As stated by the attending physician the event could possibly be related to acqguide sheath or other non-acutus medical sheaths and that the event was "definitely related" to procedure. There were several procedure-related opportunities that may have contributed to or caused the event. The procedure itself is technically demanding and carries the risk of complications including arteriovenous fistulas. Since it cannot be determined what if any role the acutus device(s) may have played in this event, acutus is conservatively reporting this event.
 
Event Description
Patient history: a female patient ((b)(6) was treated on (b)(6) 2019. The patient's history included a previous ablation in 2013 to treat the patient's atrial fibrillation (af). The patient was cardioverted in (b)(6) 2018. Description of the event: on (b)(6) 2019, a serious adverse event (ae) was reported during the acutus clinical study (recover af). It was reported that post procedure the patient developed hypotension and a drop in blood pressure. A ct scan showed a small arteriovenous fistula in the groin. There was no evidence of retroperitoneal bleeding. The drop in blood pressure was viewed to be external bleeding from a sheath removal rather than internally. The patient was diagnosed with a venous access site complication (av fistula) that led to anemia and required a blood transfusion. Two units were anticipated but following the first infusion, the patient was suspected of having a transfusion reaction (pyrexia). The second unit was not administered. It was reported that the ae was "definitely" related to procedure. The report showed there was no possible or probable relationship to acutus medical (acm) devices. Following a site monitoring visit, an update was made to the subject file on november 13, 2020. The update stated the ae was possibly related to an acutus device. The report also stated the ae was "definitely" related to procedure. On january 7, 2020 acm received an email which provided clarification from the attending physician. The physician stated that the ae was possibly related to acqguide sheath or another non-acm sheath utilized in the procedure. The report states the ae is still "definitely" related to procedure. Patient status post event: patient was in sinus rhythm upon discharge. Issue was resolved without sequelae.
 
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Brand NameACQGUIDE STEERABLE SHEATH
Type of DeviceSTEERABLE CATHETER
Manufacturer (Section D)
ACUTUS MEDICAL, INC.
2210 faraday avenue
suite 100
carlsbad CA 92008
Manufacturer (Section G)
ACUTUS MEDICAL, INC.
2210 faraday avenue
suite 100
carlsbad CA 92008
Manufacturer Contact
karen kincade
2210 faraday avenue
suite 100
carlsbad, CA 92008
4422326123
MDR Report Key11273458
MDR Text Key230688177
Report Number3012120746-2021-00002
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K162925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/07/2020
Device Model Number900002
Device Catalogue Number900002
Device Lot Number100211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/03/2021 Patient Sequence Number: 1
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