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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION RUNWAY CATHETER, PERCUTANEOUS Back to Search Results
Model Number 8575
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 08/14/2020
Event Type  Death  
Event Description

It was reported via medwatch (b)(4) that death occurred. The patient presented with recent three vein graft heart surgery which had damaged the left anterior descending artery (lad) distal to the attachment of the vein graft. The damage was repaired in the operating room but the artery likely closed the night of the surgery. The patient was noted to be hemodynamically unstable with ventricular tachycardia and with electrocardiogram changes suggestive of a cardiac infarction. The patient was taken emergently to the catherization lab. During the procedure, a model-6f runway cls3. 5 guide catheter was in use. The lad distal to the freshly placed graft was occluded;100% stenosed in the middle lad and 70% stenosed in the proximal lad. The physician tried opening the occluded segment with a balloon, but the result was suboptimal, and placement of a stent was then decided as the best option at that time. When the physician placed a 2. 25mm stent, the repaired portion of the lad was likely perforated by the graft stitching coming loose. The physician occluded the site with a balloon and decided to place a covered stent as a last resort. The smallest covered stent was 2. 5mm but there was no other option than to use the slightly bigger covered stent and try to deploy it at a lower pressure. The 2. 5mm stent got hung up in the 2. 25mm implanted stent and could not cross to the affected site. During an attempt to remove the 2. 5mm stent it likely got stripped off the balloon in the 2. 25mm implanted stent. The physician could not get any further devices distal to the 2. 25 stent even with multiple balloons. It was further noted that the cause of the patient's death was coronary artery occlusion/cardiac tamponade.

 
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Brand NameRUNWAY
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
FLEXTRONICS INTERNATIONL EUROPE B V
noblestraat 10 14
oostrum lb 5807 GA
NL 5807 GA
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10650663
MDR Text Key210458702
Report Number2134265-2020-13915
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8575
Device Catalogue Number8575
Device LOT Number0060230655
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 Received09/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/06/2020
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: 10/08/2020 Patient Sequence Number: 1
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