• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RANGER CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Enzyme Elevation (1838); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); ST Segment Elevation (2059); Tachycardia (2095); Bronchospasm (2598); No Code Available (3191)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative

Narroway, harry g, et al. "kounis syndrome after angioplasty of the superficial femoral artery with paclitaxel-coated balloon. " annals of vascular surgery, 2020 nov; volume 69:450. E17-450. E22. Date of event: date of event is unknown. Bsc became aware of the event on (b)(6) 2020. Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.

 
Event Description

Reported via journal article: narroway, harry g, et al. "kounis syndrome after angioplasty of the superficial femoral artery with paclitaxel-coated balloon. " annals of vascular surgery, 2020 nov; volume 69:450. E17-450. E22. It was reported that the patient became hemodynamically unstable requiring additional intervention and allergic reaction to paclitaxel occurred. The patient presented with rest pain afflicting her right leg on a six month background of progressively worsening claudication. Two months previously, she had undergone successful angioplasty of a stenosed left external iliac artery (eia) and an occluded left sfa with two ranger dcbs with paclitaxel coating. There were no procedural complication's, and she had no symptoms post operatively. In relation to the current presentation, the patient had palpable femoral pulses bilaterally with absent popliteal and pedal pulses on the right side, as well as chronic trophic changes and prolonged capillary refill. Arterial duplex ultrasound imaging revealed a near occlusion of the right sfa with a reduced ankle brachial pressure index (abpi) of 0. 49. The patient underwent an sfa angioplasty and stent procedure under local anesthetic and sedation. An up and over approach was taken with a retro grade puncture of the left common femoral artery (cfa) and placement of a non boston scientific sheath into the right cfa. A total of 7,000 units of intravenous heparin was administered during the case (weight 70 kg). Digital subtraction angiography confirmed a greater than 20 cm sfa occlusion. The lesion was recanalized for 10 cm before the wire passed into the subintimal plane. No re entry was possible into the true lumen at the distal target from an antegrade approach. Subsequently, a retrograde puncture was made of the right dorsalis pedis artery with successful passage of a through and through flossing wire. The lesion was predilated with a 3 x 200 mm non bsc balloon followed by a 5 x 150 mm non bsc balloon taken down from above through the 6f non bsc sheath. Residual dissection of the mid sfa was treated with a 5. 5 x 180 mm non bsc bare metal stent. Given the residual disease beyond the stent and to improve patency of the site of treatment, a 5 x 150mm ranger dcb with paclitaxel coating was deployed across the distal sfa and popliteal artery and inflated to nominal pressure in accordance with manufacturer recommendations. On inflation of the dcb, the patient became abruptly and hemodynamically unstable with hypotension (noninvasive blood pressure 60/30 mm hg) and tachycardic (heart rate 150 bpm) with warm peripheries and flushed skin changes. St elevation was noted on cardiac telemetry. The dcb was deflated and immediately removed from the patient. She was promptly intubated and ventilated and noted to have bronchospasm with reduced airway compliance. She was given a total of 70 mcg adrenaline together with crystalloid resuscitation. A urinary catheter and a right radial arterial line were placed. The left groin sheath was removed with manual compression for closure. The patient was stabilized in the theater with attainment of normal vital parameters and resolution of the cardiorespiratory and electrocardiogram (ecg) abnormalities noted earlier. She was extubated and transferred to the coronary care unit for observation on telemetry and treated empirically with heparin infusion (activated partial thromboplastin time target 45-90s) and regular dual antiplatelet therapy. Transthoracic echocardiography (tte) and coronary angiography revealed no abnormalities. The patient made a good clinical recovery with a marked improvement in her symptoms over 24 hours. Palpable pedal pulses were noted on bedside examination at the end of the case. Repeat arterial duplex imaging 48 hours after the event revealed a patent sfa with an abpi of 0. 96. At this point, the patient was able to mobilize at her baseline and was discharged on her usual dual antiplatelet therapy. She was referred to a specialist in the allergy clinic for further investigation with her consent. Intradermal allergy testing at standard concentrations was performed at the clinic for substances used in the case, with positive and negative controls. This was performed in accordance with the australian and new zealand anaesthetic allergy group published guidelines. Substances included propofol, fentanyl, chorhexidine, povidone iodine, ultravist, visipaque, omnipaque, and paclitaxel. Testing with paclitaxel yielded a significantly positive result. All other agents tested negatively. No further patient complications were reported in relation to this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRANGER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM 52146
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11036695
MDR Text Key222314756
Report Number2134265-2020-18042
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 12/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/18/2020 Patient Sequence Number: 1
Treatment
3 X 200 MM ARMADA BALLOON ABBOTT VASCULAR; 5 X 150 MM ARMADA BALLOON ABBOTT VASCULAR; 6F BRITE TIP SHEATH CORDIS, JOHNSON & JOHNSON
-
-