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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Respiratory Failure (2484)
Event Date 06/01/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The udi is unknown because the part number and lot number were not provided. Patient weight: (b)(6). The patient expired due to hemodynamic collapse on (b)(6) 2016. No additional information was provided. Concomitant medical devices: guide wire: runthrough; guide catheter: 6-french mp-2; embolic protection: 3. 0 spider. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided. The reported patient effects of angina, death, hypotension and perforation are listed in the coronary dilatation catheters (cdc), nc trek rx, global , instructions for use, as known patient effects. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the patient presented with 70 to 80% narrowing in the mid to distal saphenous vein graft (svg) to distal right coronary artery (rca). With a non-abbott 6fr guiding catheter, non-abbott guide wire, and a non-abbott embolic protection device positioned in the distal vessel area, balloon angioplasty was performed using a 3. 5x20mm non-compliant (nc) trek balloon dilatation catheter (bdc); during angioplasty, the patient experienced chest pain, bradycardia, and relative hypotension. After the 3. 5x20 trek balloon was deflated, a perforation with contrast extravasation was observed. A 4. 0x20mm nc trek bdc was then quickly advanced to the perforation site and multiple prolonged inflations were performed to help tamponade this perforation; during this balloon tamponade, the patient began to experience hemodynamic deterioration and essentially experienced bradycardic arrest. The patient was successfully resuscitated with full advanced cardiac life support protocol and intubation. Once the patient regained some hemodynamic stability, a 4. 0x19mm rx graftmaster covered stent was advanced to the perforation and was deployed with a maximum pressure of 16 atmospheres, sealing the perforation; the coronary intervention result was quite good. While the heart rhythm remained stable, the patient remained hypotensive. At this point, a non-abbott pump was implanted in the left ventricle without difficulty and full support was initiated. At this point, the patient was in a critical and guarded condition on full ventilatory and left ventricular support. The patient was transferred to the intensive care unit, where the patient condition continued to deteriorate into multi organ failure.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key5751726
MDR Text Key48242701
Report Number2024168-2016-04145
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/02/2016
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: 06/27/2016 Patient Sequence Number: 1
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