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Model Number 1012451-20
Device Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problems Air Embolism (1697); Angina (1710); Cardiac Arrest (1762)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
It is unknown if the device is returning for analysis. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Event Description
It was reported the procedure was to treat a lesion in the left anterior descending (lad) artery. Two stents were implanted and a 3. 50 x 20mm nc trek balloon dilatation catheter (bdc) was used for post dilatation when an air embolism was noted. The patient went into pulseless electrical activity (pea) arrest. Cardiopulmonary resuscitation (cpr) and advanced cardiac life support (acls) were performed. The patient regained consciousness and was transferred to the intensive care unit (icu). After the procedure, the bdc was inspected and the shaft was noted to be fractured (not separated) and torn. The patient was discharged two days later. No additional information was provided.
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. The reported patient effect of air embolism and angina is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use as a known patient effect. The investigation was unable to determine a conclusive cause for the reported complaint; however, the reported additional treatment and hospitalization appear to be related to circumstances of the procedure. A conclusive cause for the reported patient effects of air embolism, angina and cardiac arrest and the relationship to the device, if any, cannot be determined. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device. Attachment: medwatch report #mw5097625.
Event Description
Subsequent to the initially filed medwatch report, a medwatch report was received. Mw5097625. A barbeau type a exam was noted the right wrist. A 6f glidesheath was placed in the right radial artery using modified seldinger technique. 2. 5 mg verapamil was administered intra-arterially via the sheath. A 0. 035 j-wire was used to advance catheters for engagement. Heparin was administered when the catheter crossed into the ascending aorta. I engaged the left main with a 6 french ebu 3. 5 guiding catheter. I then proceeded to perform ifr assessment of both the lad and the left circumflex coronary artery. I used the volcano wire and standard technique. Ifr of the lad was 0. 87 indicating hemodynamic significance. Ifr of the left circumflex was 0. 83 indicating hemodynamic significance. Pci was indicated. I then perform primary stenting of the left circumflex with a 3. 5 x 32 mm synergy drug-eluting stent deployed at 14 atm and post dilated to 14 atm. Excellent angiograph results were obtained. I then rewired the lad with the volcano wire and performed stenting using a 3. 5 x 32 mm synergy drug-eluting stent. This was followed by stenting more proximally using a 3. 5 x 16 mm synergy drug-eluting stent deployed at 11 atm and post dilated to 14 atm. I then returned with a 3. 5 x 20 mm nc trek balloon and performed post dilation of the lad stent. At this time air embolus was noted in the left coronary system. Etiology was not completely clear. There was concern over rupture of the balloon shaft. Patient immediately had chest discomfort followed by pea arrest. This necessitated cpr and acls protocol. Eventually patient had return of consciousness and pulse. Repeat angiography confirmed resolution of air embolus with distal timl-3 flow. Patient did not require intubation. Upon of inspection of the nc trek coronary dilator catheter 3. 50 the sheath was noted to be ruptured. No additional information was provided.
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Manufacturer (Section D)
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key10876526
Report Number2024168-2020-09778
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151996
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number1012451-20
Device Catalogue Number1012451-20
Device Lot Number81016G1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Age68 YR
Patient Weight109
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;