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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TURNPIKE SPIRAL CATHETER

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VASCULAR SOLUTIONS, LLC TURNPIKE SPIRAL CATHETER Back to Search Results
Model Number 5640
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Nausea (1970); Perforation (2001); Renal Failure (2041); Collapse (2416); Loss Of Pulse (2562); Abdominal Distention (2601); Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/05/2020
Event Type  Death  
Manufacturer Narrative

Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications. A follow-up report will be issued after the investigation is complete.

 
Event Description

Subject expired post index procedure in the cto pci study in which numerous devices were used. At the end of the index procedure a perforation was noted which was treated with a covered stent. Echocardiogram showed stable pericardial effusion w/o tamponade. During evening post-procedure subject was on bedside commode c/o nausea was given a basin for emesis, however he collapsed was brought back to bed where he was found pulseless. Cpr and acls protocols were initiated. Bedside cannulation of va ecmo circuit w/ perfusion and tvp was placed. Bedside tee demonstrated stable pericardial effusion w/o evidence of tamponade. Subject was emergently brought down to cath lab for coronary reperfusion. Lmca, lad lcx om1 and om2 thrombosed, s/p ptca and aspiration thrombectomy restored timi3 flow to lmca, prox lad, lcx, om1 and om2, no flow to distal lad despite thrombectomy, ptca and vasodilator pharmacotherapy. Upon return from cath lab patient continued to deteriorate. Subject showed signs of hepatic and renal failure requiring sled. 4u prbc for significant anemia was given (hgb 6. 1 with minimal improvement after transfusion). Va ecmo rpm was increased to 4000 with improvement in flows (3. 4->4l/min) with transient improvement in hemodynamics but was returned to previous settings given persistent chugging alarms despite volume resuscitation. Subject lost all pulses in rle and had rising cpk. Intraabdominal pressure measured in setting of increasing abdominal distention was elevated (via foley catheter, 21), concerning for abdominal compartment syndrome. Given subject's progressive deterioration, subject's family was updated and came to bedside who all stated that they wished to withdraw care given subject's severely guarded prognosis. Dialysis was stopped, medications were held, and va ecmo was turned off. Shortly thereafter, no spontaneous movements were present. There was no response to verbal, tactile stimuli or sternal rubs. Pupils were mid-dilated and fixed, no pupillary light reflex noted. No breath sounds were appreciated over either lung field. No carotid pulses palpable, no heart sounds audible over precordium. Subject pronounced dead at 0422 on (b)(6) 2020. Per investigator this event is related to the procedure and not related to study devices. Mdr 2134812-2020-00100, mdr 2134812-2020-00101, mdr 2134812-2020-00102, mdr 2134812-2020-00103, and mdr 2134812-2020-00104. Mdr 2134812-2020-00105.

 
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Brand NameTURNPIKE SPIRAL
Type of DeviceCATHETER
Manufacturer (Section D)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer (Section G)
VASCULAR SOLUTIONS, LLC
6464 sycamore court north
minneapolis MN 55369
Manufacturer Contact
mary haufek
6464 sycamore court north
minneapolis, MN 55369
7636564300
MDR Report Key11088742
MDR Text Key224130954
Report Number2134812-2020-00106
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK191560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5640
Device Catalogue Number5640
Device LOT Number675243
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 Received12/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2020
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: 12/29/2020 Patient Sequence Number: 1
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