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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Occlusion (1984); Blood Loss (2597); No Code Available (3191)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative
Weight: (b)(6). Implanted date: device was not implanted. Explanted date: device was not explanted. Patient height: 152 cm. (b)(4). The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record of the product code/lot# combination was conducted with no findings. [uf medwatch (b)(4)].
 
Event Description
The user facility reported an issue of the destination slender breaking inside the patients arm during the procedure. The complaint from the physician was upon inserting the destination slender partially into the patients arm he pulled back to reposition the sheath. With the dilator in place, at that time, the sheath broke approximate 6-10cm from the hub. He continued to pull the sheath back, however, the coil started to unravel. The sheath could not be removed due to tension. Eventually, the sheath broke completely in several pieces upon trying to remove. Part of sheath was left in descending aorta and a second piece in the patients arm partially exposed and a third piece that was completely removed from body. The physician placed an 8fr sheath in the groin and attempted to snare the piece in the aorta. That piece was eventually removed. The piece remaining in the arm was eventually removed. Follow up angiogram revealed no blood flow in the arm from approximately the elbow and distal. The physician decided to take the patient to surgery to do an exploratory brachial cut down. Particulate was removed, and the patient was sent to pathology within the hospital. The patient was reported to be in stable condition, and has doppler pulses in their radial, and ulnar post exploratory surgery. It was stated that the sheaths are kept in the pixis machine. Estimated blood loss was less than 250cc. Terumo medical received a user facility medwatch report # (b)(4) on 10jun2019. The event description states: "pt with acute on chronic non-healing bilateral foot ulcers, peripheral artery disease with prior stent placement right lower extremity. On (b)(6) 2019 she underwent an abdominal angiogram with runoff to the feet, with plans to intervene on occluded superior femoral artery. When the physician attempted to pull the sheath back in order to redirect the wire, but in doing so the sheath came apart at the wrist (left radial access under ultrasound guidance) and began to unravel at which time further attempts at manual removal were halted. Attempts at retrieving by snaring the pieces was briefly attempted and unsuccessful, with a piece of the sheath occluding the left brachial artery. Consult was requested with vascular surgeon. Ultimately, the patient required surgical intervention, including extraction of brachial artery foreign body, direct repair of radial artery at the wrist, and fasciotomy of the left forearm".
 
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Brand NameR2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer (Section G)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer Contact
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key8711784
MDR Text Key148413468
Report Number1118880-2019-00139
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171491
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberN/A
Device Catalogue NumberGS-R6ST1C12W
Device Lot NumberXA03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2019
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: 06/19/2019 Patient Sequence Number: 1
Treatment
8FR SHEATH
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